Evaluation of the effects of a drug with fiscalized substance dispensation, health education, and pharmacovigilance continuing education program in Colombia drugstores and drugstores/pharmacies: study protocol of a multicenter, cluster-randomized controlled trial.

BACKGROUND: Health disorders, due to the use of drugs with fiscalized substances, including controlled substances, have become a common problem in Colombia. Multiple reasons can help explain this problem, including self-medication, since access to these drugs may be easier. Also, there is a lack of knowledge that these drugs are safer than illicit drugs. The use of these drugs without a valid medical prescription and follow-up can have negative consequences such as drug abuse, addiction, and overdose, and eventually, have negative health consequences. Pharmacy staff is essential to both assure the correct drug use and minimize prescription errors to help outpatients have better management of their pharmacotherapy. For this reason, it is necessary to increase key competencies like knowledge, skills, and attitudes in the pharmacy staff of ambulatory (outpatients) pharmacies. METHODS: This study is a prospective, cluster-randomized, parallel-group, multicenter trial of drugstores and drugstores/pharmacies (ambulatory pharmacies). The study is designed to determine the effectiveness of a drug with fiscalized substance dispensation, health education, and pharmacovigilance continuing education program in drugstores and drugstores/pharmacies. Pharmacy staff will be randomly selected and assigned to one of the study groups (intervention or control). The intervention group will receive a continuing education program for over 12 months. The control group will receive only general information about the correct use of complex dosage forms. The primary objective is to evaluate the effectiveness of a continuing education program to improve pharmacy staff competencies (knowledge, skills, and attitudes) to improve the ambulatory (outpatient) pharmacy services: dispensation, health education, and pharmacovigilance of drugs with fiscalized substances. The secondary outcomes include (a) processes associated with the management of drugs with fiscalized substances in drugstores and drugstores/pharmacies, including regulation compliance; (b) degree of implementation of ambulatory (outpatient) pharmacy services targeting these drugs in drugstores and drugstores/pharmacies; (c) patient satisfaction with such services; and (d) pharmacy staff satisfaction with the continuing education program. DISCUSSION: This clinical trial will establish whether providing a continuing education program for the adequate utilization of drugs with fiscalized substances improves pharmacy staff competencies regarding these drugs. TRIAL REGISTRATION: ClinicalTrials.gov NCT03388567. Registered on 28 November 2017. First drugstore or drugstore/pharmacy randomized on December 1, 2018. PROTOCOL VERSION: 0017102017MC.

Pharmacists in dispensing drugs (PharmDisp): protocol for a clinical trial to test the effectiveness of distance education in training pharmacists for dispensing drugs

ABSTRACT Dispensing drug is a moment in which the pharmacist is able to analyze pharmacotherapy and contribute to its rational use. However, research has shown that some pharmacists lack adequate knowledge to perform this service. This study aims to describe a research protocol for a clinical trial to test the effectiveness of a distance learning program to train pharmacists in dispensing drugs. This is a protocol for an open diagnostic, non-randomized, single group clinical trial. A 12-week duration distance learning course was structured on the Moodle platform for training community pharmacists who are registered in the Regional Board of Pharmacy and work as employees or owners in Brazilian community pharmacies. The course curricula involves concepts and practice of dispensing drugs applied to the treatment of hypertension, diabetes mellitus, dyslipidemia and asthma. Pharmacists are divided randomly into groups, to which previously selected tutors give directions to the discussion and clarify questions. A validated questionnaire is being used before and after the course to measure participants' knowledge. Participant satisfaction with the course is also being measured. Pharmacists who work in the study headquarters municipality receive two visits from a mystery shopper, before and after the course, to evaluate their performance in dispensing drugs. The virtual platform and the content of the course material were evaluated by judges. The study has been approved by the Research Ethics Committee of the School of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo. The sample size was estimated to provide desired power for testing the significance of the difference between baseline-to-endpoint change scores. Information about the course is being released through channels such as social networks. The results will be submitted for publication in scientific journals, but information enabling the identification of the study subjects will be kept confidential. The trial has been registered in The Brazilian Clinical Trials Registry with number RBR7mbrp3 on January 15th, 2015.

A Systematic Review of the Effects of Continuing Education Programs on Providing Clinical Community Pharmacy Services.

Objective. To summarize the effects of media methods used in continuing education (CE) programs on providing clinical community pharmacy services and the methods used to evaluate the effectiveness of these programs. Methods. A systematic review was performed using Medline, SciELO, and Scopus databases. The timeline of the search was 1990 to 2013. Searches were conducted in English, Portuguese, and Spanish. Results. Nineteen articles of 3990 were included. Fourteen studies used only one media method, and the live method (n=11) was the most frequent (alone or in combination). Only two studies found that the CE program was ineffective or partially effective; these studies used only the live method. Most studies used nonrobust, nonvalidated, and nonstandardized methods to measure effectiveness. The majority of studies focused on the effect of the CE program on modifying the knowledge and skills of the pharmacists. One study assessed the CE program's benefits to patients or clients. Conclusion. No evidence was obtained regarding which media methods are the most effective. Robust and validated methods, as well as assessment standardization, are required to clearly determine whether a particular media method is effective.

Brazilian National System for the Monitoring and Improvement of Compounding Practices: program outcomes.

Compounding pharmacies in Brazil have to comply with a complex and strict set of drug manufacturing regulations. The authors reported in the International Journal of Pharmaceutical Compounding (November/December 2009, Volume 13, Issue 6) on the development and implementation of a National System for the Monitoring and Improvement of Compounding Practices in Brazil, a process-focused program aiming to help compounding pharmacies improve drug manufacturing processes and meet the standards set forth by the applicable legislation This article reports the results obtained in the first three editions of the National System for the Monitoring and Improvement of Compounding Practices in Brazil (2006-2010) and presents new foci explored in the 2011 cycle. The results obtained over the years demonstrate that participating in the National System for the Monitoring and Improvement of Compounding Practices in Brazil has helped pharmacies achieve legal compliance and improve the quality of their preparations, which has contributed substantially to meeting quality standards never before achieved in the compounding sector in Brazil.

Perfil da assistência farmacêutica na coordenadoria regional de saúde sul do município de São Paulo / Profile of the pharmaceutical care

A qualidade do uso de medicamentos está diretamente relacionada à qualidade do serviço de saúde. Neste contexto, a padronização e a distribuição de fármacos tornam-se fatores primordiais para a boa avaliação destes serviços, visto que a farmácia é o elo final entre o serviço prestado pelo SUS e o usuário. A credibilidade de todo o sistema depende, entre outras coisas, do bom trabalho da farmácia. A distribuição dos serviços de farmácia, de forma regionalizada visa aproximar o usuário da satisfação de suas necessidades, colocando a sua disposição uma série de equipamentos especializados, que enriquecem a atenção básica em saúde.

Perfil da Assistência Farmacêutica na Coordenadoria Regional de Saúde Sul do município de São Paulo

A qualidade do uso de medicamentos está diretamente relacionada à qualidade do serviço de saúde. Neste contexto, a padronização e a distribuição de fármacos tornam-se fatores primordiais para a boa avaliação destes serviços, visto que a farmácia é o elo final entre o serviço prestado pelo SUS e o usuário. A credibilidade de todo o sistema depende, entre outras coisas, do bom trabalho da farmácia. A distribuição dos serviços de farmácia, de forma regionalizada visa aproximar o usuário da satisfação de suas necessidades, colocando a sua disposição uma série de equipamentos especializados, que enriquecem a atenção básica em saúde

Perfil da Assistência Farmacêutica na Coordenadoria Regional de Saúde Sul do município de São Paulo / Profile of the Pharmaceutical Care

A qualidade do uso de medicamentos está diretamente relacionada à qualidade do serviço de saúde. Neste contexto, a padronização e a distribuição de fármacos tornam-se fatores primordiais para a boa avaliação destes serviços, visto que a farmácia é o elo final entre o serviço prestado pelo SUS e o usuário. A credibilidade de todo o sistema depende, entre outras coisas, do bom trabalho da farmácia. A distribuição dos serviços de farmácia, de forma regionalizada visa aproximar o usuário da satisfação de suas necessidades, colocando a sua disposição uma série de equipamentos especializados, que enriquecem a atenção básica em saúde(AU)

[Community pharmacies' professional image: causes and improvement strategies by applying qualitative research techniques]. / Imagen profesional de farmacias comunitarias: causas y estrategias de mejora aplicando técnicas de investigación cualitativa.

OBJECTIVE: Ascertaining pharmacists' views related to factors explaining the lack of visibility of community pharmacies as being health facilities and proposing strategies for improving community pharmacy professional service accessibility using qualitative research techniques. METHODS: The nominal group technique (NGT) was used in two successive rounds using separate guidelines for factors and strategies. Framework analysis was then carried out. RESULTS: Thirty-four ideas related to "factors" and 32 related to "strategies" were obtained. Strategies were grouped into 14 topics, emphasising those prioritising patient-orientated professional services, ethical aspects and pharmacists' ongoing education. DISCUSSION: The techniques used led to identifying situations perceived by pharmacists which are not formally described in the literature. Raising awareness of professional services in community pharmacies implies agreeing on and developing strategies which should be based on joint participation by the pharmacists themselves, professional associations and universities.

Imagen profesional de farmacias comunitarias: causas y estrategias de mejora aplicando técnicas de investigación cualitativa / Community pharmacies' professional image: causes and improvement strategies by applying qualitative research techniques

Objetivo Conocer las opiniones de los farmacéuticos con relación a los factores que explican la falta de visibilidad de la farmacia comunitaria como establecimiento sanitario y proponer estrategias de desarrollo profesional a fin de lograr mejorar la accesibilidad a los servicios profesionales mediante técnicas de investigación cualitativa. Material y métodos Se utilizó una Técnica de Grupo Nominal (TGN) en 2 rondas sucesivas, respondiendo a 2 consignas guía sobre factores y estrategias. Posteriormente se realizó un Framework analysis. Resultados Se aportaron 34 ideas referidas a factores y 32 a estrategias. Las estrategias fueron agrupadas en 14 temas, destacándose las vinculadas a la priorización de los servicios profesionales orientados a los pacientes, al cumplimiento de la ética y a la formación continua del farmacéutico. Discusión Las técnicas utilizadas permitieron evidenciar situaciones percibidas por los farmacéuticos que no están formalmente descriptas en la literatura. Aumentar la visibilidad de los servicios profesionales en las farmacias comunitarias implica acordar y abordar estrategias que deben sustentarse en la participación conjunta de los propios farmacéuticos, las asociaciones profesionales y las universidades.

Objective Ascertaining pharmacists' views related to factors explaining the lack of visibility of community pharmacies as being health facilities and proposing strategies for improving community pharmacy professional service accessibility using qualitative research techniques. Methods The nominal group technique (NGT) was used in two successive rounds using separate guidelines for factors and strategies. Framework analysis was then carried out. Results Thirty-four ideas related to "factors" and 32 related to "strategies" were obtained. Strategies were grouped into 14 topics, emphasising those prioritising patient-orientated professional services, ethical aspects and pharmacists' ongoing education. Discussion The techniques used led to identifying situations perceived by pharmacists which are not formally described in the literature. Raising awareness of professional services in community pharmacies implies agreeing on and developing strategies which should be based on joint participation by the pharmacists themselves, professional associations and universities.

Strategies to increase the sensitivity of pharmacovigilance in Portugal.

OBJECTIVE: To evaluate the results of an intervention to improve the number and relevance of reports of adverse drug reactions. METHODS: A cluster-randomized controlled trial was conducted with pharmacists working in Northern Portugal, in 2007. After randomization, 364 individuals were placed into the intervention group (261 in telephone interviews and 103 in workshops), while the control group was comprised of 1,103 pharmacists. The following were approached in the educational intervention: the problem of adverse drug reaction, the impact on public health and spontaneous reporting. With regard to relevance, adverse reactions were classified into severe and unexpected. Statistical analysis was performed, based on the intention-to-treat principle; generalized linear mixed models were applied, using the penalized quasi-likelihood method. The pharmacists studied were followed during a period of 20 months. RESULTS: The intervention increased the rate of spontaneous reporting of adverse reactions three times (RR = 3.22; 95% CI 1.33;7.80), when compared to the control group. The relevance of reporting rose, with an increase in severe adverse reactions by approximately four times (RR = 3.87; 95% CI 1.29;11.61) and in unexpected adverse reactions by five times (RR = 5.02; 95% CI 1.33;18.93), compared to the control group. CONCLUSIONS: During a period of up to four months, educational interventions significantly increased the number and relevance of spontaneous reporting of adverse drug reactions by pharmacists in Northern Portugal.

La farmacoeconomía en la toma de decisiones: una perspectiva de superación profesional en Santiago de Cuba / Pharmacoeconomics in decision-making: a perspective of occupational training in Santiago de Cuba

Este estudio responde al proyecto ramal: Estrategia para el desarrollo de la Farmacoeconomía en Santiago de Cuba, del cual solo se analizó la línea de investigación denominada: Superación profesional, con la finalidad de contribuir al adecuado uso de las herramientas que brinda la fusión de ambas especialidades para la toma de decisiones en las diferentes instituciones sanitarias de la provincia, mediante acciones a realizar a corto y largo plazos en pro del perfeccionamiento y la actualización de la labor de los profesionales vinculados con esa esfera de la salud(AU)

This study responds to the branch project: Strategy for developing the Pharmacoeconomics in Santiago de Cuba, of which the line of investigation termed Occupational training was only analyzed, with the purpose of contributing to the appropriate use of tools that the combination of both specialties offers for decision-making in different health institutions of the province, by taking the short-and long-term actions for improving and updating the work of professionals linked to that health sphere(AU)

La farmacoeconomía en la toma de decisiones: una perspectiva de superación profesional en Santiago de Cuba / Pharmacoeconomics in decision-making: a perspective of occupational training in Santiago de Cuba

Este estudio responde al proyecto ramal: Estrategia para el desarrollo de la Farmacoeconomía en Santiago de Cuba, del cual solo se analizó la línea de investigación denominada: Superación profesional, con la finalidad de contribuir al adecuado uso de las herramientas que brinda la fusión de ambas especialidades para la toma de decisiones en las diferentes instituciones sanitarias de la provincia, mediante acciones a realizar a corto y largo plazos en pro del perfeccionamiento y la actualización de la labor de los profesionales vinculados con esa esfera de la salud.

This study responds to the branch project: Strategy for developing the Pharmacoeconomics in Santiago de Cuba, of which the line of investigation termed Occupational training was only analyzed, with the purpose of contributing to the appropriate use of tools that the combination of both specialties offers for decision-making in different health institutions of the province, by taking the short-and long-term actions for improving and updating the work of professionals linked to that health sphere.

Clinical pharmacy at the university hospital from São Paulo, Brazil.

Clinical Pharmacy includes all services performed by pharmacists practicing in hospitals, community pharmacies, nursing homes, home-based care services, clinics and any other setting where medicines are prescribed and used. Clinical Pharmacy activities may influence the correct use of medicines at three different levels: before, during and after the prescription is written. At the same time, pharmaceutical care philosophy is coming to Brazil. This paper comments on the development of the Clinical Pharmacy concept in Brazil, mainly in its practice and experience in the University Hospital of São Paulo.

Training pharmacy workers in recognition, management, and prevention of STDs: district-randomized controlled trial.

OBJECTIVES: To determine the effectiveness of an intervention for pharmacy workers in improving their recognition and management of sexually transmitted disease (STD) syndromes. METHODS: We randomly selected 14 districts (total population nearly 4 million) from the 24 districts of low socioeconomic status in Lima, Peru. We randomly assigned paired districts to receive training and support for management and prevention of STDs or a control intervention about management of diarrhoea. The STD intervention included interactive luncheon seminars on recognition and management of four STD syndromes (urethral discharge, vaginal discharge, genital ulcers, and pelvic inflammatory disease) and STD/HIV prevention counselling; monthly pharmacy visits by "prevention salespersons" who distributed materials that included "STD/HIV prevention packets" containing information, condoms, and cards given to patients for referral of their sex partners; and workshops for physicians on managing patients with STD syndromes referred from pharmacies. Standardized simulated patients visited pharmacies in intervention and control districts at one, three, and six months after training to assess outcomes. FINDINGS: Standardized simulated patients reported significantly better recognition and management (appropriate antimicrobial regimens provided for discharge syndromes and referral to specially trained physicians for genital ulcers or pelvic inflammatory disease) by pharmacy workers of all four STD syndromes. They also reported significantly more frequent recommendations for use of condoms and treatment of partners at pharmacies in intervention districts than in control districts (by "intention-to-train" analyses, P<0.05 for 47/48 primary outcome comparisons). CONCLUSION: Training was feasible and effectively improved pharmacy workers' practices.

Proyecto de educación en el uso racional de medicamentos en la carrera de medicina de la Universidad Técnica de Oruro / Project of education in the rational use of drugs in the career of medicine of Techinical University of Oruro

El uso racional de medicamentos es utilizar fármacos indicados, en posologia adecuada y almenor costo posible. La intervención esta destinada primero evaluar el uso racional de medicammnetos en nuestro medio, en profesionales médicos, en recién egresados y estudiantes de la Carrera de medicina de la universidad Técnica de Oruro (U. T. O), en base a programas de la de farmacologia de otras universidades del país y el exterior, donde se incluya el uso racional de existencia de un programa educativo de utilización racional de medicamentos, dirigidos a los estudiantes de la carrera de medicina, que guie al egresado sobre el uso adecuado de medicamentos, el que incide sobre el costo beneficio y la eficiencia en la pretación de servicios institucionales...

AIDS prevention training for pharmacy workers in Mexico City.

Mexican pharmacies play an important adjunct health care role in sexually transmitted disease prevention and treatment. In light of the rapid spread of the AIDS pandemic, research was initiated in 1989 to investigate the feasibility of pharmacies assisting in AIDS and STD prevention and control through community education and condom promotion. This study was implemented in three stages: a needs assessment, development of a training course and complementary materials, and an evaluation of the course and materials. The instruments used in the needs assessment were a KAP questionnaire and 'mystery shopper' visits to pharmacies. The evaluation design utilized pre- and post-tests, condom sales tracking and 'mystery shopper' visits. The needs assessment found that pharmacy employees have some basic knowledge about AIDS and STDs, but lack important information and do not communicate effectively with clients in spite of client interest in these topics. Pharmacy workers expressed great in learning more about AIDS and STDs. The evaluation of the intensive 8-hour course and supporting materials showed that, when given together, the course and materials increased short term knowledge about AIDS and condom use. However, the interventions were less successful in achieving longer term information retention, transfer of knowledge to clients or in influencing condom sales. Adjustments in the training course content and in participant recruitment strategies are recommended.

Leucopenias por medicamentos / Leukopenia by drugs

Em estudo retrospectivo realizado no Centro de Hematologia de Säo Paulo, envolvendo a análise de 10.000 casos no período de 5 anos, avaliou-se a frequência de reaçöes adversas a medicamentos que provocassem leucopenia, agranulocitose e aplasia medular e sua classificaçäo de acordo com os critérios estabelecidos pelo "Registry of Tissue Reactions to Drugs". Constatou-se que leucopenias, agranulocitose e aplasia medular como reaçäo adversa a medicamentos säo relativamente raras, incidindo no total, em um centro especializado, na proporçäo de 2 em 1000 casos. A concomitância em alguns caos de produtos ditos "naturais" faz os autores discutirem a necessidade de controle e normalizaçäo no uso de tais produtos )

A descriptive analysis of pharmacy continuing education offerings in 1985.

This study reports the results of a national survey of ACPE-approved provider continuing education offerings during 1985. The study was designed to identify frequently-presented topics, characterize types of programs offered, describe the providers offering programs and detail continuing education activities on a regional basis. Data were requested through the mail and the ACPE "program description form" was used as the source of the study data. Two hundred and one (84.1%) ACPE-approved providers from eight regions of the country and Puerto Rico participated and data from 2,461 programs were analyzed. Differences and similarities among programs offered and characteristics of providers were reported. Additional information was generated on when programs were offered, methods of presentation, average tuition charged and average credit hours offered. Significant differences were noted. Comparisons with previous national studies were made where possible. Among the findings was: an impact by mandatory continuing education requirements on the number of programs available; an increase in average program tuition charges; a decrease in the average number of credit hours per program; and an increase in competition among providers. Programs provided a rich variety of offerings, required a moderate tuition charge, were offered in every month, and used many different formats and delivery methods.