Pharmaceutical Professionals Research Articles

O Notícias Farmacêuticas e o retrato da profissão farmacêutica em Portugal

O Notícias Farmacêuticas e o retrato da profissão farmacêutica em Portugal

Healing the Rift Between the Pharmaceutical Industry and Pharmacy Profession with Joint Guidelines

SUMMARYThis paper discusses how the rift between industry and the profession has hurt both, leading to the commoditization of some drugs and services. In an effort to close the rift, a working document was developed by state pharmacy associations and PhRMA titled “Guiding Principles for a Pharmacy Benefit: A Call for Pharmacy Provider Services and Access to Pharmaceuticals.” The principles provide mutual recognition of the roles of both industry and the profession and an agreement around which alliances can be developed in response to state legislation that does not recognize the role pharmacists or innovative pharmaceuticals play in improving patient outcomes.

The Notícias Farmacêuticas and the portrait of the pharmaceutical profession in Portugal

The Notícias Farmacêuticas and the portrait of the pharmaceutical profession in Portugal

Introducing theJournal of Pharmaceutical Innovation

With the International Society for Pharmaceutical Engineering (ISPE) and Elsevier, and on behalf of the Pilot Journal Task Team, I am pleased to introduce the Journal of Pharmaceutical Innovation (JPI) to the pharmaceutical community. JPI is a scientific peer-reviewed publication that will focus on current topics of interest to the pharmaceutical industry, including new technologies, methods, products, philosophies, and the associated regulatory issues. JPI is intended to be of interest to a broad audience of pharmaceutical professionals and will include research and review papers in the areas of manufacturing, applied pharmaceutical sciences, process control, quality, pharmaceutical engineering, and pharmaceutical technology. The Editorial Advisory Board wishes to have an emphasis on new and innovative methods and techniques for the pharmaceutical industry. As Ajaz Hussain has commented in his Editorial article, the FDA’s current initiatives have, in fact, played an important part in the development of this Journal. The initiative on Process Analytical Technology (PAT), the current Good Manufacturing Practices for the 21st Century, and the Critical Path Initiative have accelerated the rate of change in our industry, and have also helped to create a niche for JPI. Although the technologies, methods, and philosophies associated with the PAT initiative, for example, might be important topics for current issues of JPI, the Pilot Journal Task Team and the Editorial Advisory Board envision the Journal as a forum for communication regarding any important new issues in the pharmaceutical manufacturing industry. Continuous processing, individualized drug therapy, nanoparticles for improved drug delivery, novel analytical techniques, and many other potential topics come to the Editor’s mind as important subjects to be addressed in coming issues of JPI; however, the pharmaceutical community will bear the ultimate responsibility for identifying such topics. The Editor wishes to thank ISPE, Elsevier, and the Pilot Journal Task Team for their efforts to bring this Journal to reality. Additionally, the authors who have bravely submitted the fruits of their efforts to a new Journal are to be thanked. The reader will find a broad range of important topics in this first issue, including:

The division of labour in healthcare - the role of the pharmacist

Many actors in health care would like to abolish the pharmaceutical profession. Politicians in search of further cost saving alternatives have seized upon the retail margins of pharmacies. Many physicians bear antipathy towards their competitor for the scarce financial health care resources. And in times of e-commerce and industrially produced drugs, many people are convinced that pharmacists are dispensable. Therefore, pharmacists should commonly provide competent and helpful advice to patients and physicians, learn more about the politics of the health system and become more flexible than at present. Unfortunately, they are not on the right path yet. This paper describes the need for action and concludes that pharmaceutical faculties must impart not only learning about chemistry and galenics, but also a profound knowledge of the health system, social skills, cost structures and the clinical benefit and cost-benefit-ratio of drugs.

Concepções do profissional farmacêutico sobre a assistência farmacêutica na unidade básica de saúde: dificuldades e elementos para a mudança

No presente estudo foi feita avaliação da Assistência Farmacêutica em farmácias de Unidades de Saúde do município de Ribeirão Preto, no Estado de São Paulo, Brasil. Partindo-se do referencial de avaliação tecnológica em saúde e suas interfaces, foram realizadas entrevistas com os profissionais farmacêuticos, procurando-se conhecer as concepções desses atores sobre a assistência farmacêutica. Os resultados obtidos mostram um trabalho baseado na gestão burocrática dos medicamentos com objeto no controle de estoque do medicamento. Alguns elementos emergentes que poderão contribuir para a alteração deste quadro foram detectados: voluntarismo, busca pela valorização profissional, iniciativa de integração com a equipe de saúde, percepção do paciente como objeto de trabalho e formação profissional complementar.

Drug delivery strategies for common orofacial diseases

There are many types of diseases associated with the oral cavity. As an adjunct to professional oral dental care, various drug delivery systems have been developed to improve the treatment or prevention of these diseases. In this manuscript, the current status of drug delivery strategies for these common orofacial diseases is reviewed. Biomineral-binding drug delivery and on-demand drug release are suggested to be considered in the future design of drug delivery systems for orofacial diseases. Apparently, this research field deserves much more attention from both pharmaceutical scientists and dental health professionals.

Critical success factors for establishing a multidisciplinary health community knowledge management system using internet-based ICTs: the cardiology paradigm

The current paper concerns the development of an internet-based Health Community Knowledge Management System in the field of Cardiology. The research conducted covers a wide range of state-of-the-art technologies (ontologies, knowledge management techniques, etc.). The objectives of the final system are: to create an ontology for the modelling of the knowledge base around cardiology, while facilitating every day working needs of the various intended end users. Pharmaceutical companies, healthcare professionals, and biomedical companies are all interested and are participating in the formation of the virtual community for disseminating valuable knowledge in cardiology. The technological challenges of applying such an internet-based system, as well as the sociocultural and political factors affecting the application of similar internet-based ICTs and the integration with existing processes and systems in healthcare are examined. The research was conducted in three countries/pilot sites (Greece, Spain and Italy) and two experiences for testing purposes are being considered. The work concludes that some of the major success factors are: • knowledge critical mass • political commitment and endorsement • well-structured ontology • multilinguality of the content and the system • timeless processes • multipartnership participation • patient- and problem-oriented knowledge management system.

Décret du 15 juin 1888, premier décret réglementant l'exercice de la pharmacie en Tunisie, et évolution de la législation pharmaceutique avant et après l'indépendance

In 1881, the French protectorate is established in Tunisia whose independence will not be officially declared before March 20th, 1956. This article presents the content of the decree of June 15th, 1888, the first text that legislates pharmacy practice in Tunisia. The publication of this decree, a real fundamental text, did not put an end to the illegal practice of pharmacy in the Regency, which could be explained by the few shortcomings of the text, the legislator's inability to implement the law, the ignorance and the inadvertency of the diplomats, and also the "regime of the surrenders" (le régime des capitulations) which, by preventing the pharmaceutical inspection, gave free rein to all the offenders. This situation led in the course of time to the promulgation of a number of laws which progressively allowed a better organization of the pharmaceutical profession in the Regency. The progress made by the pharmaceutical legislation throughout the French protectorate continued after the independence of Tunisia as is attested by the law number 73-55 of August 3rd, 1973 which is still in use at present.

Professional Code or Legal Sanctions: Pharmacy in China

This paper examines how norms are introduced and implemented in the production and trade of medicines in China, with some reference to similar cases in Australia. The aim is to analyse the role of the State in the supervision of the pharmaceutical industry in China. The professional responsibility of the apothecary whose wares can cure or destroy a patient has always been self-evident in any cultural environment. The question to be raised here is not so much what these responsibilities are in China but who defines them and how they are defined. The starting point for analysis is a set of materials concerned with the Chinese pharmaceutical industry. The materials consist of The People's Republic of China's Full Account of Administrative Practices in Regard to Pharmaceuticals (Zhonghua Renmin Gongheguo Yaopin Guanli Shiyong Quanshu), published in 1997, and similar administrative guidelines from the 1980s and 1990s. In China there are no guidelines for the pharmaceutical industry equivalent to those in Australia, which originate from within the industry.1 The origin and style of the Chinese materials will shape much of the following discussion. In China, administrative rules or laws must be seen as the main creator and guarantor of norms prevailing in the production and trade of pharmaceuticals. Thus, unlike Australia where the validity of a pharmacists' professional code reduces the need for legal sanctions, in China the definition of professional standards and the control over their implementation are exclusively a matter for legal sanctions. This feature of Chinese pharmaceutical practice results from the dominant role of the Chinese state; its strict monopoly in regard to social organisation and a certain institutional weakness that results from this are factors that necessarily curtail the self-determination of professional groups. So in this respect, despite the special issues involved in the production and sale of pharmaceuticals, pharmacists do not differ much in regard to their professional sovereignty or, rather, the lack of it from other professions. Consequently, in order to identify the Chinese understanding and formulation of professional ethics for pharmacists, we first need to look at the issue of the status of the pharmaceutical profession in China.

Law as a Study Orientation in Pharmacy Education in Romania

Pharmaceutical legislation is the subject-matter that studies the norms or rules of law that apply to the pharmaceutical profession and the field of the drug. For this reason, it is a borderline subject-matter between pharmaceutical sciences and legal sciences. By its contents, pharmaceutical legislation belongs to the science of law; by its destination, it belongs to the science of pharmacists. This paper presents arguments in favour of modernizing the approach to the subject-matter of Pharmaceutical Legislation, like Pharmaceutical Law, at the Faculty of Pharmacy in Romania, as well as a possible model for structuring the curriculum of the subject-matter.

Extemporaneous Prescribing: Whatever Happened to It? A Survey of Australian General Practitioners

Objectives: Recent Australian and New Zealand studies have shown that dispensing of extemporaneous products by pharmacists has declined over recent years to only 1 to 2% of total prescriptions. The purpose of this study was to survey general practitioners (GPs) to identify the scope of extemporaneous prescribing, reasons for any limitations to such prescribing and their interest in further education.Method: A mail survey comprising eighteen questions was distributed by eleven Divisions of General Practice from five Australian States to 1138 GPs.Results: 318 replies were received which equated to aresponse rate of 28%. 52% of respondents were male with 87% from inner city/suburban practices. The primary source of instruction in extemporaneous prescribing was either experience (48%) or medical school (25%), and the majority (68%) either never or rarely prescribed extemporaneous preparations. The main reasons given were lack of product knowledge (78%) and items not being listed on the Pharmaceutical Benefits Scheme (29% ). When extemporaneous products were prescribed, the most common were topical (31% often or very often) and eye/ear/nose (16% often or very often). Despite the overall low level of extemporaneous prescribing, there was considerable interest (94% overall) in accessing information on these products with at least two‐thirds of respondents considering that the Internet would be a useful or very useful medium for accessing appropriate information.Conclusion: Although extemporaneous products are no longer commonly prescribed, the majority of GPs surveyed do not see these products as ‘a thing of the past’, and expressed a desire to learn more. There may be an opportunity for the medical and pharmaceutical professions to collaborate in maintaining this traditional area of practice.

Discriminating measures of bronchodilator drug efficacy and potency.

Bronchodilator drugs, used alone or in conjunction with inhaled corticosteroids or other anti-inflammatories, are essential to the effective management of asthma [1, 2]. The three main categories of effective bronchodilators are inhaled β2-adrenoceptor agonists and anticholinergics, and methylxanthines, particularly oral theophylline. The incidence of asthma continues to rise, however, enhancing the need to develop new bronchodilator drugs and products and to evaluate their therapeutic efficacy, potency and cost-effectiveness in relation to existing treatments [3]. The short-acting β2-adrenoceptor agonist salbutamol, in a pressurized metered dose inhaler (pMDI), has long been the most widely used bronchodilator, and a key factor influencing the requirement for new products is the phasing out of chlorofluorocarbon (CFC) pMDI propellants to curtail damage to the stratospheric ozone layer [4]. The pharmaceutical industry is also responding to a decade of off-patent availability of effective asthma drugs including salbutamol and the anticholinergic ipratropium bromide, which has encouraged the development of novel generic bronchodilator/inhaler device combinations [5]. This combination of factors has led to a pressing need to develop the most economical and precise methods of evaluating efficacy and potential clinical equivalence of inhaled bronchodilators with the traditional pMDI and current alternatives in order to satisfy both clinicians and regulatory authorities. Clinical equivalence of drugs relates to both potency and safety since the lowest effective dose must be used in order to minimize systemic side-effects. Measures of bronchodilator drug efficacy have in the past relied on direct measurement of the induced bronchodilatation by lung function testing. This often does not, however, allow potency discrimination between drug products, since a single dose can result in maximal bronchodilatation. This has led both clinicians and pharmaceutical professionals to develop more sensitive, repeatable, and therefore more discriminating methodologies employing alternative patient populations and alternative efficacy endpoints. Dose–response data are fundamental to the accurate measurement of both efficacy and systemic effects. Importantly, regulatory authorities are also addressing these issues [6–8]. This review focuses on β2-adrenoceptor agonist studies to highlight the discriminating measures of bronchodilator drug efficacy and potency which should enable a valid comparison of novel and traditional inhaled asthma treatments. (Measures and methodologies are summarized in Table 1.) Table 1 Comparison of methodologies for testing of bronchodilator efficacy.

British community pharmacists' views of physician-assisted suicide (PAS)

Objectives— To explore British community pharmacists' views on PAS , including professional responsibility, personal beliefs, changes in law and ethical guidance. Design— Postal questionnaire Setting— Great Britain Subjects— A random...

Co-ordinated Care

Co-ordinated care is being trialled in Australia. People with long-term complex and chronic conditions are participating in satellite trials to see if different management and care co-ordination leads to better quality of care, more efficiently delivered. While the trials are under way, significant public statements have been made about co-ordinated care by the government, the professions, notably the medical and pharmaceutical professions, and the community. This paper examines some of those statements, and comments on the input into an ongoing ethics debate of resource allocation in healthcare. Efficiency and quality are recurring themes in this public debate. The process of change is compared to initiatives in the US and UK.

Medical Center Clinical Rotation for Pharmaceutical Drug Information Professionals

Drug information practitioners can be at a disadvantage in that they do not work directly in patient-care environments. This article describes a clinical rotation program developed to enable Parke-Davis drug information colleagues to experience a contemporary patient care environment at a local medical center. In March 2000, 13 Parke-Davis drug information professionals completed one-day rotations at Morristown Memorial Hospital. The general medicine clinical rotation provided meaningful experience in observing state-of-the-art health care, helped drug information colleagues better relate to the situations that health professional customers face, fostered more effective communication with health care professionals and patients, and provided a better appreciation of patient-care literature and in preparing drug information-medical communications that refer to and discuss patient care situations. Morristown Memorial Hospital has been invited to participate in a rotation program at Parke-Davis.

Johann August Kruse (1822-1895), Leader in Melbourne's Nineteenth-Century Chemical and Pharmaceutical Professions.

Historical Records of Australian Science publishes peer-reviewed articles and book reviews on the history of science and scientists in Australia and the southwest Pacific, biographical memoirs of deceased Fellows of the Academy, and an annual bibliography of the history of Australian science

Patient understanding of postsurgical instruction forms

An estimated 20 to 48 million adults in the United States are functionally illiterate, and the number is reportedly increasing. The medical, nursing, and pharmaceutical professions have pioneered examination of the issues surrounding the readability of written instructions, but little introspection has been presented in the dental literature on the subject. Written instructions have been shown to be a valuable supplement to verbal instructions, but many forms and brochures are written at too high a grade level for many patients to be able to read and understand them. Materials should be written in a way that makes it possible for patients to understand them even if those patients read at a sixth- to eighth-grade level. This article examines the issues surrounding the writing of patient instructions and makes recommendations for improvements. Future clinical research is proposed. (Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1999;87:153-8)

製薬企業の行うPMSとその方法論

Post-marketing surveillance (PMS) of ethical drugs has been institutionalized in Japan. The framework of the PMS consists of : 1) collection of information related to the drug, 2) evaluation and analysis of that information, and determining the correspondence, 3) reporting the information and filing of applications of Reexamination/Reevaluation to the Ministry of Health and Welfare (the Koseisho), and finally 4) dissemination of information to medical and pharmaceutical professionals. Although a sphere of strict regulations is imposed for conducting these tasks, pharmaceutical companies comply with these regulations and execute post-marketing surveillance with an aim toward the true objective of the PMS, which is to “secure the proper use of ethical drugs”. In order to accomplish this objective, nothing is more important than for medical representatives (MR) to collect as much accurate information as possible, and for post-marketing surveillance management to conduct a precise evaluation and analysis of the collected information and then to feed back the pertinent information to medical and pharmaceutical professionals. With this in mind, pharmaceutical companies can be considered as conducting post-marketing surveillance systematically.

Science, Politics, and the Pharmaceutical Industry: Controversy and Bias in Drug Regulation

Drug disasters from Thalidomide to Opren, and other less dramatic cases of drug injury, raise questions about whether the testing and control of medicines provides satisfactory protection for the public. In this revealing study, John Abrahan develops a theoretically challenging realist approach, in order to probe deeply into the work of scientists in the pharmaceutical industry and governmental drug regulatory authorities on both sides of the Atlantic. Through the examination of contemporary controversial case studies, he exposes how the commercial interest of drug manufacturers are consistently given the benefit of the scientific doubts about medicine safety and effectiveness, over and above the best interests of patients.; A highly original combination of philosophical rigour, historical sensitivity and empirical depth enables the black box of industrial and government science to be opened up to critical scrutiny much more than in previous social scientific study. All major aspects of drug testing and regulation are considered, including pre- clinical animal tests, clinical trials and postmarketing surveillance of adverse drug reactions. The author argues that drug regulators are too dependent on pharmaceutical industry resources and expertise, and too divorced from public accountability. The problem of corporate bias is particularly severe in the UK, where regulatory decisions about medicine safety are shrouded in greater secrecy than in the US.; Since the purpose of drug regulation should be to maximize the safety and effectiveness of medicines for patients, the public needs and deserves policies to counteract corporate bias in drug testing and evaluation. John Abraham's realist analysis provides a robust basis for policy interventions at the institutional and legislative levels. He proposes that corporate bias could be reduced by more extensive freedom of information, greater autonomy of government scientists from pharmaceutical industry, the development of independent drug testing by the regulatory authority, increased patient representation on regulatory committees, and more frequent and thorough oversight of regulatory performance by the legislature. This book should be of interest to anyone who cares about how medicines should be controlled in modern society. It should prove particularly rewarding for students and researchers in the sociology of science and technology, science and medicines policy, medical sociologists, the medical and pharmaceutical professions, and consumer organizations.