To Set Up Norms for Drug Safety and Inspection: To Guarantee Administrative Sufficiency and Avoid Regulators from Being Wrongly Punished.

Currently, as there is no systematic norm or standard for drug safety and inspection, it cannot be judged whether the regulatory authority or regulators have fulfilled their administrative responsibilities entirely or not, when a drug safety-related incident occurs. And there is a probability that some may even be wrongly punished. In this study, we have analyzed the risk of not having appropriate norms in place and also put forward recommendations for the government or the regulatory authorities to set up norms to be fulfilled for drug safety and inspection issues. This, on one hand, could provide a basic guideline for the regulatory authorities and regulators to improve their professional levels and administrative acumen and on the other hand, it could also provide a baseline for society to judge whether the regulatory authorities and regulators have fulfilled their responsibilities correctly and thereby also help prevent regulators from being mistakenly punished. This study proposes that a systematic and functional norm for drug safety and inspection could be set up relating to the determination of the responsibilities of regulatory authorities and scope of various inspections, number and frequency of inspections, number and qualifications of regulators, handling of inspection results, inspection records, and disciplinary codes for inspectors. This study also puts forward suggestions on who should be responsible for drafting the norms and what are the factors that need to be considered while formulating the norms.

Underestimating the toxicological challenges associated with the use of herbal medicinal products in developing countries.

Various reports suggest a high contemporaneous prevalence of herb-drug use in both developed and developing countries. The World Health Organisation indicates that 80% of the Asian and African populations rely on traditional medicine as the primary method for their health care needs. Since time immemorial and despite the beneficial and traditional roles of herbs in different communities, the toxicity and herb-drug interactions that emanate from this practice have led to severe adverse effects and fatalities. As a result of the perception that herbal medicinal products have low risk, consumers usually disregard any association between their use and any adverse reactions hence leading to underreporting of adverse reactions. This is particularly common in developing countries and has led to a paucity of scientific data regarding the toxicity and interactions of locally used traditional herbal medicine. Other factors like general lack of compositional and toxicological information of herbs and poor quality of adverse reaction case reports present hurdles which are highly underestimated by the population in the developing world. This review paper addresses these toxicological challenges and calls for natural health product regulations as well as for protocols and guidance documents on safety and toxicity testing of herbal medicinal products.

The inclusion of a business management module within the master of pharmacy degree: a route to asset enrichment? / Inclusión de un módulo de gestión de empresa en el grado de master en farmacia: ¿un camino hacia la mejora?

Background: Over the past decade the profession of pharmacy has steadily evolved. The New Pharmacy Contract exposed pharmacists to a fundamental change in traditional pharmacy business models. Objective: This study will consider whether community pharmacists, pharmacy undergraduates and academic staff within the United Kingdom believe it would be beneficial to incorporate a business management module within the Master of Pharmacy (MPharm) undergraduate degree along with potential mechanisms of delivery. Methods: Further to ethical approval, the questionnaire was distributed to UK registered pharmacists (n=600), MPharm undergraduates (n=441) and academic staff at Liverpool John Moores University (n=44). The questions were formatted as multiple choice questions, Likert scales or the open answer type. On questionnaire completion and return, data were analysed using simple frequencies, cross tabulations and nonparametric techniques in the SPSS (v18). Results: The majority of pharmacists (84.9%) confirmed that business skills affect their everyday responsibilities to a considerable extent. A high proportion of undergraduate students (92.8%) believed that business management skills will impact on their future role. In total, 64.3% of this cohort declared that if a module were introduced they would study it. The majority of staff (79%) agreed that business skills are gaining increased importance within the field of pharmacy. Conclusions: Data suggest that business skills are of relevance to the practice of pharmacy. Appropriate staff to deliver the taught material would include business owners / lecturers and teaching practitioners covering topics including management, leadership, interpersonal skills and regulation. We suggest the inclusion of a business module with the MPharm degree would be of great value in preparing individuals for practice within a modern day healthcare setting (AU)

Antecedentes: Durante la década pasada, la profesión de farmacia ha evolucionado firmemente. El New Pharmacy Contract expuso a los farmacéuticos a un cambio en los modelos tradicionales de negocio. Objetivo: Este estudio considerará si los farmacéuticos, estudiantes de farmacia y académicos en Reino Unido se beneficiarían incorporando un módulo de gestión de empresa en el grado de Master en Farmacia (MPharm) así como los potenciales mecanismos de enseñanza. Métodos: Después de la aprobación de ética, se distribuyó el cuestionario e farmacéuticos en ejercicio en Reino Unido (n=600), estudiantes del MPharm (n=441) y personal académico de la Liverpool John Moores University (n=44). Las preguntas tenían formato de preguntas de elección múltiple, escalas de Likert o preguntas abiertas. Cuando se cumplimentaban y retornaban los cuestionarios, se analizaron los datos usando frecuencias simples, tablas cruzadas y técnicas noparamétricas con el SPSS (v18). Resultados: La mayoría de los farmacéuticos (84,9%) confirmó que las habilidades empresariales afectan sus responsabilidades diarias en grado considerable. Una proporción elevada de estudiantes (92,8%) creía que las habilidades en gestión empresarial tendrían impacto en su papel futuro. En total, el 64,3% de esta cohorte declaró que si se introdujese un módulo, lo estudiarían. La mayoría del personal académico (79%) concordó que las habilidades empresariales están ganando importancia en el campo de la farmacia. Conclusiones: Los datos sugieren que las habilidades empresariales son de relevancia en la práctica de la farmacia. El personal adecuado para proporcionar el material docente debería incluir propietarios, y profesores de prácticas que cubran los temas como gestión, liderazgo, habilidades interpersonales y legislación. Sugerimos que la inclusión de un módulo de empresa en el grado de MPharm sería de gran valor en la preparación de los individuos para el ejercicio en los establecimientos sanitarios modernos (AU)

[Experience on equipment supervision and inspection in food and drug control agency].

To assure the effective operation of certification and accreditation in the laboratory management system, further strengthen the instruments and equipment management, and provide specific recommendations on improvement of internal audit, management review and continuous improvement of management system. The inspector program had been firstly established and complemented. Through the inspection, we identified many deficiencies, made many specific recommendations for improvement. After inspection, the working procedures were improved; data from department were more rigorous, scientific and just; hardware foundation was established for international mutual recognition.

[Update on the Mali Pharmacy Code: legislative section]. / Essai de mise au point d'un code de la pharmacie au Mali: partie legislative.

Due to colonization (1895-1960) Mali has been submitted, on the legislative and regulation plan to a corpus of numerous and scattered texts relative to pharmacy. It is essentially the Law AN XI of 21 Germinal or the 11 April 1803 Law; the content of Book V of the Public Health Code relative to pharmacy practice, of which some disposals have been extended to Overseas Territories, Togo and Cameroon in 1953; the 1955 Ministerial Order about the dispatching of the Retail Pharmacy in AOF; the 1960 Law creating the Board of Pharmacists in the Federation of Mali etc. After independence, the new Malian State while renewing the pharmacy legislation issued by the old tutor State which was not opposed to the new fundamental Law, has also set up, according to the political orientations of the moment, some new texts. In the framework of this work, we have collected all the legislative and regulation texts that have been allowed in Mali in the pharmacy area and in that of Studies in Pharmacy. We have examined those texts and proceeded to codify the legislative part. The present Code consists of 189 articles divided in 5 titles layed out in chapters and sections.

[Update on the Mali Pharmacy Code: legislative section]. / Essai de Mise au Point D'un Code de la Pharmacie au Mali : Partie Legislative.

Due to colonization (1895-1960) Mali has been submitted, on the legislative and regulation plan to a corpus of numerous and scattered texts relative to pharmacy. It is essentially the Law AN XI of 21 Germinal or the 11 April 1803 Law; the content of Book V of the Public Health Code relative to pharmacy practice, of which some disposals have been extended to Overseas Territories, Togo and Cameroon in 1953; the 1955 Ministerial Order about the dispatching of the Retail Pharmacy in AOF; the 1960 Law creating the Board of Pharmacists in the Federation of Mali etc. After independence, the new Malian State while renewing the pharmacy legislation issued by the old tutor State which was not opposed to the new fundamental Law, has also set up, according to the political orientations of the moment, some new texts. In the framework of this work, we have collected all the legislative and regulation texts that have been allowed in Mali in the pharmacy area and in that of Studies in Pharmacy. We have examined those texts and proceeded to codify the legislative part. The present Code consists of 189 articles divided in 5 titles layed out in chapters and sections.

La gestión farmacéutica en el Sistema Nacional de Salud / No disponible

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Re-examining 'professionalism' in pharmacy: a South African perspective.

Although defining itself as a patient-centred profession, private sector (community and private hospital) pharmacy often appears to be that of a product-for-profit centred occupation. This perception has been at the core of the medical profession's attempts to reduce the professional autonomy of pharmacy, and has appeared at the forefront of the South African Department of Health's positioning of private sector pharmacy. Using as a starting point the debate surrounding attempts by the South African Minister of Health to regulate the price of medicines, I propose that the present negative positioning of private sector pharmacy in South Africa could be ameliorated by pharmacy practice that evidences a redefined understanding of professionalism.

Disponibilidad y coexistencia de especialidades farmacéuticas publicitarias con otras especialidades de igual composición / No disponible

En la actualidad en España existen tres tipos de medicamentos en función de su estatus de dispensación: los que necesitan receta médica y los que no la necesitan; estos últimos pueden ser publicitarios (les está permitido hacer publicidad de los mismos dirigida a la población) o no publicitarios. A los medicamentos publicitarios se les reserva la denominación de Especialidades Farmacéuticas Publicitarias, tienen una legislación específica y los principios activos que las componen y las condiciones en las que éstos puedan utilizarse han de estar previamente autorizados por Orden Ministerial. El presente trabajo pretende conocer cuantos de estos principios activos autorizados disponen de Especialidades Farmacéuticas Publicitarias en el mercado y si existen medicamentos de diferente estatus de dispensación con la misma composición cuali y cuantitativa que las Especialidades Farmacéuticas Publicitaria y en qué grado puede darse esta coexistencia. Cerca de la mitad de los principios activos autorizados para medicamentos publicitarios no cuenta con ninguno de ellos comercializado. El arsenal terapéutico del que puede disponer el farmacéutico en la dispensación de especialidades farmacéuticas de su competencia es más reducido del que la legislación vigente permite, dándose la circunstancia de que para determinados trastornos menores que pudieran tratarse con EFP, solamente se disponen de Especialidades Farmacéuticas de prescripción médica. Se produce coexistencia entre EFP y especialidades de prescripción médica para un mismo principio activo autorizado. Esto se da en concretamente en 29 casos (10,01%). Esto es causa de problemas para el farmacéutico comunitario por la ambigüedad de la norma y por sus consecuencias jurídicas (AU)

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La Cooperativa de Hospitales de Antioquia y la política farmacéutica nacional / The Cooperative of Hospitals of Antioquia and the pharmaceutical national policy

Se presenta una síntesis de las principales acciones desarrolladas durante los últimos años por la Cooperativa de Hospitales de Antioquia —Centro colaborador de la Organización Mundial de la Salud y la Organización Panamericana de la salud—, concordantescon la política farmacéutica de Colombia. Igualmente, se analiza la forma como estas acciones han contribuido a su desarrollo e implementación en el país

Tribunal Constitucional: transmisibilidad vs concesiones. Más vale tarde que nunca / Constitutional Court: transmission vs concession. Better late than never

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[Non-technical causes of fakes existing in Chinese medicinal material markets].

Non-technical causes of fakes existing in Chinese medicinal materials markets come from three aspects. Source of Chinese medicinal materials is complex and it is difficult to trace back to a source; lawless add impurities and use inferior goods pretending to superior quality and illegally seek for profit; supervising department lack strict blow and deterrent force is limitted.

[Technical causes of false and inferior species appearing in Chinese medicinal materials markets].

The result indicated that technical causes of false and inferior appearing in the Chinese medicinal materials markets consisted of two respects essentially. First, the men who violated the law and committed a crime used certain weak link existing in quantity analysis of country's medicinal standard. Second, it is difficult that basic units managing and using drug implement effective technical supervision.

Implantación de la Atención Farmacéutica. Sistemas de retribución y papel de la Administración / Implementation of Pharmaceutical Care. Reimbursement systems and the Administration role

No disponible