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Counterfeit medicine. A threat to health. Legal situation / El medicamento falsificado. Una amenaza para la salud. Situación legal

The existence of substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products is an unacceptable risk to public health, becoming an emerging problem in recent years. However, we should be aware that the phenomenon of counterfeiting is not a novelty since such practice coexists with human beings since time immemorial. In the present work we will do a partial analysis of counterfeiting situation from a legislative point of view and will analyze how various legal and non-legal instruments have been used trying to resolve this issue in the European context

La existencia de medicamentos falsificados es una realidad. Se trata de un problema emergente en los últimos años. Sin embargo, hemos de ser conscientes que el fenómeno de la falsificación no es un hecho novedoso ya que tal práctica convive con el ser humano desde tiempos pretéritos. En el siguiente texto se realizará un análisis parcial de la situación de los mismos desde su punto de vista legislativo y se analizará cómo se han utilizado diversas herramientas jurídicas y no jurídicas para intentar solventar esta problemática existente a nivel comunitario

La formación científica y ejercicio profesional en España de Vicente Cervantes Mendo / Scientific training and professional practice in Vicente Cervantes Mendo's Spain

Vicente Cervantes Mendo (Ledrada, Salamanca, 1758-México, 1829) fue un insigne científico hispanomexicano; hoy es patrimonio de España y México. Como una continuación de dos artículos recientes sobre su vida en España, este artículo trata de su formación científica, como farmacéutico y como botánico, y de su ejercicio profesional en Madrid. Dos informes de Casimiro Gómez Ortegade 1786, catedrático primero del Real Jardín Botánico de Madrid, en relación con la Real Expedición Botánica a nueva España (1787-1803), han servido para establecer conclusiones que precisan los aspectos estudiados y corrigen errores (AU)

Vicente Cervantes Mendo (Ledrada, Salamanca, 1758-México, 1829) was a famous SpanishMexican scientific; he is today heritage of Spain and Mexico. As a continuation of two recent articles on his life at Spain, the present study deals with his scientific formation at Madrid, as pharmacist and as botanist, as well as on his professional activity. Two documents of Casimiro Gómez Ortega, principal professor of the Real Jardín Botánico de Madrid, dated in 1786 and related with the Real Expedición Botánica a Nueva España (1787-1803), have served to establish conclusions which clarify the subjects studied and correct mistakes (AU)

Global education implications of the foreign pharmacy graduate equivalency examination.

Although the Foreign Pharmacy Graduate Equivalency Examination (FPGEE) is not intended to measure educational outcomes or institutional effectiveness, it may be a reliable and valid criterion to assess the quality or success of international pharmacy programs. This comprehensive review describes the evolution and historical milestones of the FPGEE, along with trends in structure, administration, and passing rates, and the impact of country of origin on participant performance. Similarities between the FPGEE and the Pharmacy Curriculum Outcomes Assessment (PCOA) are also explored. This paper aims to provide a global prospective and insight for foreign academic institutions into parameters for evaluating their students' educational capabilities.

The NAPLEX: evolution, purpose, scope, and educational implications.

Since 2004, passing the North American Pharmacist Licensure Examination (NAPLEX) has been a requirement for earning initial pharmacy licensure in all 50 United States. The creation and evolution from 1952-2005 of the particular pharmacy competency testing areas and quantities of questions are described for the former paper-and-pencil National Association of Boards of Pharmacy Licensure Examination (NABPLEX) and the current candidate-specific computer adaptive NAPLEX pharmacy licensure examinations. A 40% increase in the weighting of NAPLEX Blueprint Area 2 in May 2005, compared to that in the preceding 1997-2005 Blueprint, has implications for candidates' NAPLEX performance and associated curricular content and instruction. New pharmacy graduates' scores on the NAPLEX are neither intended nor validated to serve as a criterion for assessing or judging the quality or effectiveness of pharmacy curricula and instruction. The newest cycle of NAPLEX Blueprint revision, a continual process to ensure representation of nationwide contemporary practice, began in early 2008. It may take up to 2 years, including surveying several thousand national pharmacists, to complete.

[Prosecution of Mélanie Hahnemann in 1847 at the court of Paris: illegal practise of pharmacy and medicine]. / Le procès de Mélanie Hahnemann en 1847 à Paris, exercice illégal de la pharmacie et de la médecine.

Recently married, the Hahnemanns came to Paris in 1835. The great man, 80, was authorised to practice in France. His wife Mélanie always assisted him in writing prescriptions, and in recruiting patients. When he died in 1843, she was continuing to practise assisted or not by a physician, Deleau or Croserio. A young pharmacist, Charles LeThiére, lived close to her as her adoptive son, grandson of the famous painter Guillaume Guillon-LeThière who was the director of the French Academy of Fine Arts of Rome at the Villa Medici, grandson as well of the Roman pharmacist Giuseppe Meli. Early Charles remained orphan and was educated by Mélanie. In 1844, he obtained his pharmaceutical graduation at the Ecole supérieure de Pharmacie de Paris. In 1847, she was accused of illegal practising of medicine and pharmacy. She claimed that she held the degree of doctor in homeopathy granted to her by the Academy of Pennsylvania. The court condemned her on the medical side considering that she earned money without legal certification in medicine. But as the drugs were prepared by a pharmacist, and delivered free of charge to the patients, no sentence was pronounced against her neither against LeThière. However, the court tempted to object that LeTière did not meet all the legal requirements for practising his pharmaceutical activity, especially aruging that he did not own an open shop of pharmacy, and that he did not declare his activity to the authorities in Paris. This point underline the fact that during the XIXth century the French law (21 germinal An XI- 1803), obliged the starting drug industry to be in dependence of the shops of pharmacy opened to the public, owned by a graduated pharmacist. As defender Mrs. Hahnemann chose the quite known solicitor Chaix d'Estange. Many testimonies came for justifying her capability of medical prescribing from artists, officers, writers and several aristocrats. From abroad came the supports of American doctors, Hempel, Hering and Hull. But the core question motivating her sentence came from the medical lobby acting in Paris led by the professor Orfila. Among the adepts of the homeopathy themselves, raised division and rivalry, but all considering that Mélanie Hahnemann's behavior was criticable. The court fined her for hundred francs that she paid. Then, she kept the circle of her friends and continued in medical counselling.

[How, why, when and for how long time did the Danish veterinarians have the right to dispense drugs?]. / Hvordan, hvorfor, hvornår og hvor loenge havde danske dyrloeger ret til at dispensere loegemidler?

Danish veterinarians are still allowed to prescribe and distribute drugs sold by Danish pharmacies to be used for treatment of animals under their care in agreement with the Danish rules and EU directives (4). Since the first student graduated from Danish Veterinary School in 1775, Danish veterinarians have also, in agreement with their education, had the right to dispense drugs produced in their own dispensary. However, due to the development of the methods for drug production, the introduction of registered products from medical companies, and the justified demands for documentation of drug efficacy and safety was abolished in 1988, and no exemptions were granted after January 1st 1990 (1). The controlled use of drugs with documented efficacy and safety has improved the clinical effect of animal treatment, minimized side effects in treated animals and unwanted effects on the environment and the consumers of animal products (22).

[The illegal exercise of pharmacy during the XIXth century]. / L'Exercice illégal de la pharmacie au XIX Siècle.

During the XIXth century, the courts judged many cases of illegal exercise of pharmacy. The persons concerned were doctors, members of clergy, grocers, quacks... The writer analyses many decisions and shows the importance of the jurisprudence as a source of the right during this century.

[A pharmacist diploma cancelled twelve years after its issue]. / Un diplôme de pharmacien annulé douze ans après sa délivrance.

A grocer from Nancy became chemist for making steel balls exclusively. Many years complaints conducted to diploma cancellation. A new degree gained later was disputed again, but without result.

[The Protomedicato Tribunal and apothecaries in 18th century Barcelona]. / Protomedicato y boticarios en la Barcelona del siglo XVIII.

In this article we attempt to expand our current understanding of the training and licensing of Early Modern apothecaries. We identify, through the study of the evolution of licensing control, some problems of general interpretation regarding the relationship between physicians and apothecaries in the context of Bourbon health policies in 18th century Barcelona. We offer an explanation of this conflict based on an understanding of the historical framework of the Ancien Régime.

[The lawsuit of apothecary Lluis Mariner against the College of Apothecaries of Barcelona (1631-1635)]. / El plet de l'apotecari Lluis Mariner contra el Col-legi d'Apotecaris de Barcelona (1631/1635). Ludovicus Mariner Pharmacopula de Barña contra Consols del Col-legi Pharmacopolarum.

The author describes the litigation between the "Col-legi d'Apotecaris de Barcelona" and Lluis Mariner, a pharmacist of Barcelona and supplier of the Spanish galleys. Mariner was absolved of the charges, but the author questions himself about the reasons of the Col-legi.