[Drug Information Provided to Patients and Public-Present Regulatory Status and Future Prospects].

When taking a drug one must keep in mind certain risks and benefits based on the safety and efficacy information. One of the most reliable sources of information that enables patients to use drugs properly is package inserts, which are regulated under the law and therefore should include valid and accurate contents. With the recent revision of the Pharmaceutical and Medical Device Act, the information contained in the package insert, which was provided together with the drug, will now also be provided electronically and separately from the drug itself. In addition, a digital code will be displayed on the product packaging so that the latest information of the drug can be obtained from outside the package by scanning the code. The more drug information gets shared among healthcare professionals, patients and the public, the less the asymmetry in drug information among them will exist. It is necessary now more than ever to establish a framework and a system to ensure that sufficient information is provided to patients and the public to encourage their proper use of drugs. I believe that it is important for patients and the public to strive for a better understanding of drug information. It is also crucial for all relevant parties involved in drug information to work together on how best to utilize the information. In this way they would keep trying so that therapeutic effects could be maximized and the risks of side effects are minimized.

[Current Status and Development of Drug Information Infrastructure System for the Public in Japan and Overseas].

With the progress of medical treatment, information on drugs, etc. is overflowing on the media and the Internet, and some of them are leading to uncertain information for the purpose of profit, and some of them are wrong information or inaccurate information, and the effect on the patient is regarded as a problem. In Japan, information on public pharmaceuticals for patients and consumers is provided on the Internet, but its utilization is not sufficient. In the Pharmaceuticals and Medical Devices Act, it is stated that "Citizens shall endeavor to use pharmaceuticals, etc., properly and deepen their knowledge and understanding of their efficacy and safety". On the other hand, there is a variety of information available on the Internet, and simply searching does not necessarily lead to reliable information. It is necessary to provide information with a mechanism to ensure that the information is reliable so that it can lead to appropriate medical care. Overseas, medical information infrastructure systems, including highly reliable public pharmaceuticals based on evidence, have been developed. Examples include National Health Service (NHS) in the United Kingdom, MedlinePlus in the United States, and National Prescribing Service (NPS) MedicineWise in Australia. In the era of digital health, it is necessary to discuss issues and prospects for the construction and dissemination of information provision infrastructure that meets the needs of patients and consumers from the perspective of industry, government, academia, and patients.

[Expectations of an Academic Detailer from a Pharmaceutical Industry Perspective].

In the pharmaceutical industry, a Medical Affairs ("MA") professional collects, organizes and transmits information about a health care product based on the judgment of science, medicine and ethical values, thereby optimizing the product's value, improving corporate value, and assuring quality medical care. The role of the MA is to construct a "medical strategy" through the process of collecting, analyzing and evaluating information. On the other hand, Academic Detailing is "a new approach to drug information that actively disseminates drug comparison information from a pharmacological viewpoint, linking the drug's foundation to clinical practice." Cooperation between Academic Detailing and a pharmaceutical company's MA will be an essential relationship in realizing advanced prescribing proposals in the future, with the ultimate goal of optimal medication regimes for patients.

Trends in the receipt of medicines information among Finnish adults in 1999-2014: a nationwide repeated cross-sectional survey.

OBJECTIVE: The aim of this study was to examine long-term trends in the receipt of medicines information (MI) among adult medicine users from 1999 to 2014. DESIGN: Repeated cross-sectional postal survey from the years 1999, 2002, 2005 and 2008-2014. SETTING: Each study year, a new nationally representative sample of 5000 Finns aged 15-64 years was drawn from the Population Register Centre of Finland. PARTICIPANTS: The range of annual respondents varied from 2545 to 3371 and response rates from 53% to 67%. Of the total responses (n=29 465), 64% were from medicine users (n=18 862, ranging by year from 58% to 68%). OUTCOME MEASURES: Receipt of information on medicines in use within 12 months prior to the survey from a given list of consumer MI sources available in Finland. RESULTS: Physicians, community pharmacists and package leaflets were the most common MI sources throughout the study period. Receipt of MI increased most from the Internet (from 1% in 1999 to 16% in 2014), while decreased most from physicians (62% to 47%) and package leaflets (44% to 34%), and remained stable from community pharmacists (46% to 45%) and nurses (14% to 14%). In 1999, of the medicine users 4% did not report receipt of MI from any of the sources listed in the survey, while this proportion had remarkably increased to 28% in 2014. CONCLUSIONS: Healthcare professionals and package leaflets had still a dominating importance in 2014 despite the growing number of MI sources over time, but still a minority of adult medicine users reported receiving MI via the Internet in 2014. Worrying is that the proportion of adult medicine users who did not receive MI from any of the sources became seven fold during the study period.

Talk shows and t-tests: Applying an analogy from late-night television to biostatistics in an introductory drug information course.

PURPOSE: The use of patient cases to demonstrate the applicability of new knowledge to pharmacy practice is common; however, cases can be a challenge in first-year pharmacy courses as students have often not yet acquired sufficient knowledge in pharmacology, therapeutics, and pharmacy practice. In these situations, the use of analogy to link the educational content to a lived experience may be more effective. DESCRIPTION: This article presents my experience with applying an analogy from popular culture, specifically a game on a network late-night talk show, to a first-year pharmacy course on drug information. INTERPRETATION: An informal assessment of students' familiarity with the talk show found that most had seen at least one episode of the show and the specific game being used as the comparator in this analogy. The widespread availability of video clips online can provide additional opportunities for students unfamiliar with the comparator to receive this exposure. The use of this analogy added interactivity, humor, and mixed-media teaching to the classroom. Future applications of this and similar analogies will try introducing the analogy in reverse order - by first presenting the video of the comparator and then describing its relevance to the course content to ensure the analogy is relevant to most students before it is linked to course material. CONCLUSIONS: Teaching strategies in the first year of pharmacy education must consider students' existing level of therapeutic knowledge. When this knowledge is insufficient to ensure accurate and comprehensive understanding of patient cases, analogy may provide an effective alternative strategy.

Importance of Pharmaceutical Training and Clinical Research at Medical Facilities.

To respond to advancements in medical techniques, and to address the separation of medical and dispensary practices, clinical professors are required to educate human resource staff to become highly-skilled pharmacists. For this purpose, it is extremely important for these professors to learn about cutting-edge practical skills and knowledge, as well as to advance their expertise. In addition, they need to conduct clinical research in cooperation with relevant facilities. As our university does not have its own hospital or pharmacy, it is important to provide training for clinical professors in clinical facilities. Such training mainly involves medical teams' in-hospital rounds and participation in conferences (nutrition support team; NST), operation of the pharmacy department, and intervention targeting improvement in the department's duties. We have conducted collaborative studies, provided research instructions, implemented studies aimed at improving the department's work (pharmacists appointed on wards at all times to ensure medical safety) as well as studies regarding team medical care (nutritional evaluation during outpatient chemotherapy), and resolved issues regarding this work (drug solution mixability in a hand-held constant infusion pump, and a safe pump-filling methods). Thus, it has become possible to keep track of the current state of a pharmacists' work within team medical care, to access information about novel drugs, to view clinical and prescription-claim data, to cooperate with other professionals (e.g., doctors and nurses), to promote pharmacists' self-awareness of their roles in cooperative medical practice, and to effectively maintain the hospital's clinical settings.

Fulfilling an Unmet Need: Roles for Clinical Pharmacists in Preconception Care.

Preconception care refers to a set of interventions that identify and address biomedical, behavioral, and social risks to a woman's health that may negatively impact a future pregnancy. A great need for preconception care currently exists in the United States, and women's attitudes about discussions with health care providers about healthy and safe pregnancies are positive. Clinical pharmacists are well positioned to work with other health care and public health professionals to ensure that all women of childbearing potential have access to preconception care. As part of the collaborative health care team, clinical pharmacists can directly provide services or support and referrals to other members of the health care team or to community resources through clinical-community linkages. Specifically, clinical pharmacists can provide education, counseling, and/or services to women to address family planning, medication and disease state management, immunizations, screenings, health promotion, and substance use. Clinical pharmacists can also impact preconception care through drug information services, advocacy, and research. Preconception care services can be incorporated into daily pharmacy practice, and there are potential means for reimbursement. Multiple roles exist for clinical pharmacists to fulfill unmet needs in preconception care.

[For the Establishment of an Informative Support Framework in Pharmacies: Informative Support System for Diabetes].

According to the Japanese revitalization strategy endorsed by the government in June, 2013, pharmacies are expected to play an active role as the hub of health information. But this is not sufficiently organized: an infrastructure for providing neutral information which becomes the basis of such health information is not yet established for healthcare professionals, patients and consumers. As for drug information available subsequent to the marketing of pharmaceutical products, information from the pharmaceutical companies including Package Inserts and Interview-forms are often found. However, though such information from companies is important, it is necessary for healthcare professionals and patients to have access to the information evaluated by a trustworthy third party. With overseas distribution, the dissemination of drug information is provided by third parties, which are independent of regulatory agencies. For example, National Health Service (NHS) Evidence in the UK offers wide-ranging information based on evidence from a disease to pharmaceutical products, and is a widely available information source for healthcare professionals, patients and consumers. With regard to therapeutic medications, drug information and health foods in the Japanese community, it is necessary for patients and healthcare professionals that we establish neutral and common systematic information based on the research evidence. By providing information on the Internet, which enables people to access the information easily and to assess a product's usefulness objectively, we hope to eventually develop a system that ensures a patient's safety in the use of drugs.

Drug Information Services Today: Current Role and Future Perspectives in Rational Drug Therapy.

Polypharmacy and complex drug treatment regimens are becoming increasingly common, which may lead to adverse drug reactions, drug interactions, medication nonadherence, and increasing costs and thus challenge the rational use of drugs. At the same time, the accessibility of drug information increases, and health care professionals may have limited opportunities and capabilities to search and critically evaluate drug information. Clinicians have reported difficulties in searching the best evidence and translating study findings into clinically meaningful information applicable to specific patients. Consequently, it remains a challenge to ensure the rational use of drugs in the years to come. Drug information centers (DICs) have been established to promote the rational use of drugs. One of the most important tasks of DICs is the question and answer services for health care professionals posing drug-related questions. DICs staffed by pharmacists and clinical pharmacologists hold expertise in searching for drug information and critical evaluation of the literature. The uniqueness in this service lies not only in the identification and interpretation of the scientific literature but also in the adaptation of the findings into specific clinical situations and the discussion of possible solutions with the enquirer. Thus, DICs could provide valuable decision support to the clinic. Taking into account the increasing number of possible drug-related questions that will arise today and in the future, the DICs will remain highly relevant in the years to come. However, the DICs must follow the developments in health information technology to disseminate relevant, unbiased drug information to old and new users of the service. Moreover, the DICs are important tools to counterbalance the drug information published by the pharmaceutical industry.

An overview of upcoming changes in pregnancy and lactation labeling information / Revisión de los próximos cambios en la información sobre medicamentos en embarazo y lactación

Background: Many medications can be used safely and effectively to provide health benefits for disease state management during pregnancy with minimal risk to the fetus or mother. Today nine out of ten women take at least one medication during pregnancy, and the number of women taking four or more medications has more than doubled over the past 30 years. However, the lack of safety data combined with the generalizations of the current risk category system (A, B, C, D, X) makes risk versus benefit assessment difficult. Discussion: In response to these concerns, the U.S. Food and Drug Administration (FDA) has decided to implement a new pregnancy and lactation labeling rule designed to improve risk versus benefit assessment of drugs used in pregnant and nursing mothers; this rule is set to take effect in June of 2015. This change is designed to provide clear and detailed information for both patients and healthcare providers pertaining to three main categories: pregnancy, lactation, and females and males of reproductive potential. The new labeling rule also removes the previous letter risk categorization system. Conclusion: The upcoming changes regarding pregnancy and lactation safety labeling are going to have a vast impact on drug safety interpretation and prescribing practices. While this rule will provide practitioners with more detailed information pertaining to pregnancy, lactation, and reproduction, it will also place more responsibility on the practitioners to ensure the safety of their patients. This review will summarize these changes and discuss their potential effect on clinical practice (AU)

Antecedentes: Muchos medicamentos pueden ser utilizados con seguridad y efectividad para mejorar la salud en la gestión de enfermedades durante el embarazo con mínimo riesgo para la madre o el feto. Hoy, 9 de cada 10 mujeres toman al menos un medicamento durante el embarazo, y el número de ellas que toma 4 o más medicamentos se ha más que doblado en los últimos 30 años. Sin embargo, la falta de datos de seguridad, combinada con las generalizaciones de la actual categoría de riesgos (A, B, C, D, X) hace difícil la evaluación riesgo contra beneficio. Discusión: En respuesta a estas preocupaciones, la U.S. Food and Drug Administration (FDA) ha decidido implantar una nueva regla de información en embarazo y lactación diseñada para mejorar la evaluación riesgo contra beneficio de los medicamentos usados em madres embarazadas o lactando; esta regla entrará en vigor en junio de 2015. Este cambio está diseñado para proporcionar una información clara y detallada tanto para pacientes como para profesionales de la salud comprendiendo 3 apartados principales: embarazo, lactación, y potencial reproductivo masculino y femenino. La nueva información elimina el anterior sistema de categorización por letras. Conclusión: Los próximos cambios en la información de seguridad de embarazo y lactación van a producir un gran impacto en la interpretación de la seguridad en las prácticas de prescripción. Mientras esta regla proporcionará a los facultativos una información más detallada sobre embarazo, lactación y reproducción, también les dará más responsabilidad para asegurar la seguridad de sus pacientes. Esta revisión resume estos cambios y discute sus efectos potenciales sobre la práctica clínica (AU)

[The French National Compound Library: advances and future prospects]. / Chimiothèque Nationale - Avancées et perspectives.

The French National Compound Library (Chimiothèque Nationale) has been created in 2003 and is the federation of local collections. It contains more than 56 000 small molecules and natural compounds synthesised or isolated in different laboratories over the past years. This explains the diversity of the collection. The strength of this initiative is the ability to connect chemists and biologists for the development of hits. This development involves the synthesis of analogues or/and chemical tools to find new targets. These collaborations lead to the identification of new chemical probes. These probes able to modulate a biological function are essential to study biological pathways. They can also be useful for therapeutic applications. This article will describe the major achievements and perspectives of the French Chemical Library.

The drug prescription network: a system-level view of drug co-prescription in community-dwelling elderly people.

Networks are well suited to display and analyze complex systems that consist of numerous and interlinked elements. This study aimed at: (1) generating a series of drug prescription networks (DPNs) displaying co-prescription in community-dwelling elderly people; (2) analyzing DPN structure and organization; and (3) comparing various DPNs to unveil possible differences in drug co-prescription patterns across time and space. Data were extracted from the administrative prescription database of the Lombardy Region in northern Italy in 2000 and 2010. DPNs were generated, in which each node represents a drug chemical subclass, whereas each edge linking two nodes represents the co-prescription of the corresponding drugs to the same patient. At a global level, the DPN was a very dense and highly clustered network, whereas at the local level it was organized into anatomically homogeneous modules. In addition, the DPN was assortative by class, because similar nodes (representing drugs with the same anatomic, therapeutic, and pharmacologic annotation) connected to each other more frequently than expected, indicating that similar drugs are often co-prescribed. Finally, temporal changes in the co-prescription of specific drug sub-groups (for instance, proton pump inhibitors) translated into topological changes of the DPN and its modules. In conclusion, complementing more traditional pharmaco-epidemiology methods, the DPN-based method allows appreciatiation (and representation) of general trends in the co-prescription of a specific drug (e.g., its emergence as a heavily co-prescribed hub) in comparison with other drugs.

[Topics from "Overseas Drug Safety Information" in the past five years].

The Drug Safety Information Section of the Division of Safety Information on Drug, Food and Chemicals has been providing bulletins titled "Overseas Drug Safety Information" in Japanese since 2003. These bulletins comprise summarized and translated reports of important post-marketing drug safety information that are published by foreign regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medical Agency. A new issue of the bulletin is posted every two weeks on the website of the National Institute of Health Sciences, Japan; to date (May 2013), a total of 280 issues have been posted, covering approximately 2400 foreign news items and articles since its inception. Recently, visits to the bulletin website have been increasing: the number of hits for each issue totaled 570,000 in fiscal 2012. Among the "Overseas Drug Safety Information" issued in the past five years, I briefly describe here several topics which interested me: erythropoietin-stimulating agents in chronic kidney disease and their cardiovascular risk; bisphosphonates and atypical femur fracture; effectiveness of oral liquid cough medicines containing codeine in children; bevacizumab for metastatic breast cancer; and congenital abnormality associated with the use of antiepileptic drugs by pregnant women. I also describe the potential safety signals identified by FDA using its Adverse Event Reporting System, and their importance in ensuring the safe use of drugs in the post-marketing phase.

Review of calls to an Australian teratogen information service regarding psychotropic medications over a 12-year period.

BACKGROUND: Telephone counselling services are increasingly utilised by consumers to obtain contemporary and confidential information about perinatal drug and toxin exposure. The use of such services in regard to psychotropic agents is unknown. AIM: To determine the frequency and types of calls to a New South Wales (NSW)-based telephone counselling service regarding perinatal psychotropic agent exposure between 2000 and 2011. METHODS: Retrospective analyses of MotherSafe call data between two epochs: I (2000-2005, n = 46,277) and II (2006-2011, n = 118,587), total 164,864 calls. RESULTS: 25,698 (15.6%) calls were made about psychotropic agents: 16,218 (9.8%) about antidepressants, 3,145 calls (1.9%) about mood stabilisers/antiepileptic agents, 2,878 (1.7%) about benzodiazepines and 3,457 (2.1%) about antipsychotic drugs. Calls regarding psychotropic agents doubled in epoch II (18,231 vs 7,467, epoch I) but decreased as a proportion of total calls (I: 16.1% vs II: 15.4%, P < 0.001). Selective serotonin inhibitors (SSRIs) were the most common drugs of concern (>44% of total psychotropic calls). The proportion of calls regarding particular agents changed significantly between epochs, for example paroxetine (epoch I: 14.8% vs epoch II: 6.7% of all antidepressant calls, P < 0.001) and quetiapine (epoch 1: 10.6% vs epoch II: 34.7% of all antipsychotic calls (P < 0.001). Calls from rural areas of NSW increased from 22.6 to 24.7% (P < 0.001). CONCLUSION: Consumer demand for information about the use of psychotropic agents for women of child-bearing age has increased considerably over the last decade, particularly in rural areas of Australia. This indicates a need to review current existing services, particularly for rural consumers.

Unapproved drugs--the drug information pharmacists' perspective.

Pharmacists in all areas of practice frequently dispense or recommend drugs without realizing that some commonly used medications have never received Food and Drug Administration (FDA) approval. Most of these medications have been available for many years and are usually misconceived as generic drugs, when in fact they never went through the required quality, safety, and efficacy testing required by FDA. As a result, unapproved drugs can pose serious safety risks to patients and create uncertainty in the market. FDA established the "Unapproved Drugs Initiative" to protect public health by decreasing the number of available unapproved drugs with minimal disruptions to the market. Unapproved drugs remain in the market for various historical reasons. It is important for health care providers, particularly pharmacists, to be knowledgeable about unapproved products and consider switching patients to FDA-approved alternatives if possible when selecting drug therapy. Several resources are available on the FDA Website to determine approval status. Although FDA is working to remove unapproved drugs from the market, there will be circumstances when the use of unapproved drugs is medically necessary and appropriate. In these cases, pharmacists can monitor for and report adverse events and stay informed regarding any changes in approval status.

Desarrollo y validación de un cuestionario de satisfacción de pacientes con el seguimiento farmacoterapéutico en farmacias comunitarias / Development and validation of a patient satisfaction questionnaire on pharmaceutical care in community pharmacies

Objetivo. Desarrollar y validar un cuestionario de rápida administración para valorar la satisfacción de los pacientes con el servicio de seguimiento farmacoterapéutico (SFT) en las farmacias comunitarias españolas. Material y métodos. Se diseñó un cuestionario autoadministrable semiestructurado centrado en la percepción de los pacientes sobre la experiencia acumulativa con el servicio de SFT. El mismo fue revisado por un panel de 8 expertos en 2 rondas. La validación se realizó en farmacias comunitarias que aceptaron participar y que prestaban el servicio de SFT. Se incluyeron a todos los pacientes o a sus cuidadores que concurrieron durante el período de estudio y que supieran leer y escribir. A fines de valorar las evidencias de validez como estructura interna se realizó un análisis factorial exploratorio de componentes principales y la fiabilidad se estimó a través del coeficiente alfa de Cronbach. Resultados. Participaron 8 farmacias comunitarias pertenecientes a 7 provincias de España y se obtuvieron 103 cuestionarios. El análisis factorial reveló un único componente explicando el 33,6% de la varianza total. Se obtuvo un coeficiente alfa de Cronbach de 0,75. Los pacientes expresaron comentarios adicionales en un 9,7% de los cuestionarios que se relacionaron a resaltar la atención recibida y a agradecer por el servicio de SFT recibido. Conclusiones. El cuestionario desarrollado ha presentado evidencias de validez de contenido, validez como estructura interna y fiabilidad para valorar la satisfacción de los pacientes con el servicio de SFT en las farmacias comunitarias españolas (AU)

Objective. To develop and validate a rapid administration questionnaire to assess patient satisfaction with the pharmaceutical care (PhC) service in Spanish community pharmacies. Methods. A semi-structured and self-administered questionnaire was designed focused on the cumulative experience of patients with the PhC service. This was reviewed by a panel of 8 experts in 2 rounds. The validation was carried out in community pharmacies that performed the PhC service and agreed to participate. All patients or their caregivers who attended a pharmacy during the study period, and who could read and write, were included. An exploratory factor analysis was performed to assess the validity as evidence of internal structure and reliability was estimated using Cronbach's alpha coefficient. Results. A total of 8 community pharmacies belonging to 7 provinces of Spain took part and 103 questionnaires were obtained. Factor analysis revealed a single component explaining 33.6% of the total variance. We obtained a Cronbach's alpha coefficient of 0.75. Patients additional comments expressed in 9.7% of the questionnaires were related to emphasising, and thanking for, the care provided by the PhC service. Conclusions. The questionnaire developed has provided evidence of content validity, internal structure validity, and reliability to assess the patient satisfaction with the PhC service in Spanish community pharmacies (AU)