The evolution of postgraduate vocational education and training in pharmaceutical medicine is described alongside the growth of this scientific-medical discipline and profession for the development of new medicines. Over the past 50 years, whilst the training of competent professionals for their work has been paramount, this has paralleled the need to engage with the rapid and complex changes in R&D technologies, patient and healthcare system needs, and the ethical and regulatory obligations applied to the development of medicines throughout their lifecycle. The move from unstructured training to formal programs with syllabus, curricula and assessments for certification, has been accompanied by educational changes to outcomes-based, learner-centered, competency-based programs. The evolution of education and training along with the development of the set of 57 core competencies for professional practitioners in pharmaceutical medicine are described within the competence framework of seven domains: discovery of medicines and early development; clinical development and clinical trials; medicines regulation; drug safety and surveillance; ethics and subject protection; healthcare marketplace; communication and management. The application of the core competencies in a harmonized, international platform of education and training in medicines development at the undergraduate, postgraduate and continuing professional development levels would invigorate the potential for having a competent workforce with the intent to provide faster access to better and appropriate medicines for patients worldwide.
New edition of succesful standard reference book for the pharmaceutical industry and pharmaceutical physicians! The Textbook of Pharmaceutical Medicine is the coursebook for the Diploma in Pharmaceutical Medicine, and is used as a standard reference throughout the pharmaceutical industry. The new edition includes greater coverage of good clinical practice, a completely revised statistics chapter, and more on safety. Covers the course information for the Diploma in Pharmaceutical Medicine Fully updated, with new authors Greater coverage of good clinical practice and safety New chapters on regulation of medical devices in Europe and regulation of therapeutic products in Australia
The practice of pharmaceutical medicine brings with it ethical challenges and dilemmas often very different from those encountered in the practice of clinical medicine. Having established a framework of guiding ethical principles, this report aims to look in some detail at specific areas of possible ethical concern to pharmaceutical physicians, offering practical advice and guidance on good practice. The report covers issues related to pharmaceutical research, including dissemination of research findings, communication with other health professionals and patients and involvement of pharmaceutical physicians and companies in the provision of patient services. The primacy of the interests of patients and the wider public is emphasised, and the possible impact of new developments in pharmaceutical technology is explored. It is hoped that the report will help those working in pharmaceutical medicine and act as a stimulus for wider discussion and debate.
Appropriate prescribing is an essential medical practice of physicians. However, physicians prescribing behaviors are likely to be affected by promotional activities of pharmaceutical industries and their representatives. In this paper, we sought to explore where physicians obtain information on pharmaceutical medicines; factors influencing their medication prescriptions; and experiences of prescribing. Three public hospitals and 28 doctors were purposively sampled. Structured in-depth interviews were conducted and data were transcribed and analyzed thematically. Results show that pharmaceutical representatives are the main sources of information on pharmaceutical drugs. Patient factors such as financial status; medical diagnosis and condition; and type of patient influenced physicians’ prescribing practices. Physicians’ experiences on drug prescription practices were mixed. Requests for prescriptions were mostly for over-the-counter medicines. Majority of physicians reported that patients’ noncompliance to prescriptions was due to perceived superiority of alternative plant medicines. There is a need for stricter regulation on marketing nonprescribed pharmaceutical products to avoid fatal health implications through consumption of nonprescribed medicines.
European law has been faced with increasingly complex issues emerging from rapid developments in pharmaceutical medicine and biotechnology. A team of distinguished European legal practitioners and academics reassess the impact of European law on health care and pharmaceutical law. The essays are grouped under four themes: Free movement of goods and persons, competition and intellectual property; European drug regulation; Biotechnology; and Product liability and transnational health care litigation. The book reviews the impact of European law on movement of health care professionals and pharmaceuticals, patent and trademark rights, the Product Liability Directive, laws on product liability and intellectual property claims. It examines recent developments in drug regulation, particularly data protection, abridged applications for marketing authorisations and the European Medicines Evaluation Agency. A compelling analysis is made of the Biotechnology Directive morality clauses. This important study offers a valuable resource for the pharmaceutical and biotechnology industries, legal academics and practitioners alike.
Principles and practice of pharmaceutical medicine , Principles and practice of pharmaceutical medicine , کتابخانه دیجیتالی دانشگاه علوم پزشکی و خدمات درمانی شهید بهشتی
Primary school children aged between 10 and 15 years old in a rural community in western Kenya are frequently ill and have considerable knowledge of both herbal remedies and pharmaceuticals in treating common illnesses, such as headache, cold, fever, abdominal complaints and injuries. This paper explores this area of children's medical knowledge and practice, looking at children's ideas about and categorisation of illness and medicines, and their perceptions of medicinal efficacy. Differences between children in their medicinal knowledge and the relation between children's knowledge and that of adults in the community are described. Children appear to learn about medicines and medical practices in an informal, experiential and experimental way, from practical involvement in the treatment of illness in the family, and the authors suggest that the ways in which children learn about medicine should be further explored. The paper contributes to the literature on lay treatment of illness by focusing on children's knowledge of medicinal treatments in a context of medical pluralism.
I. INTRODUCTION Infectious diseases kill over 10 million people each year, more than 90 percent of whom are in the developing world.1 The leading causes of illness and death in Africa, Asia, and South America-regions that account for four-fifths of the world's population-are HIV/AIDS, respiratory infections, malaria, and tuberculosis. In particular, the magnitude of the AIDS crisis has drawn attention to the fact that millions of people in the developing world do not have access to the medicines that are needed to treat disease or alleviate suffering. Each day, close to eight thousand people die of AIDS in the developing world.2 The reasons for the lack of access to essential medicines are manifold, but in many cases the high prices of drugs are a barrier to needed treatments. Prohibitive drug prices are often the result of strong intellectual property protection. Governments in developing countries that attempt to bring the price of medicines down have come under pressure from industrialized countries and the multinational pharmaceutical industry. The World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS or Agreement), which sets out the minimum standards for the protection of intellectual property, including patents for pharmaceuticals, has come under fierce criticism because of the effects that increased levels of patent protection will have on drug prices. While TRIPS does offer safeguards to remedy negative effects of patent protection or patent abuse, in practice it is unclear whether and how countries can make use of these safeguards when patents increasingly present barriers to medicine access. The Fourth WTO Ministerial Conference, held in 2001 in Doha, Qatar, adopted a on TRIPS and Public Health (Doha Declaration or Declaration) which affirmed the sovereign right of governments to take measures to protect public health. Public health advocates welcomed the Doha as an important achievement because it gave primacy to public health over private intellectual property, and clarified WTO Members' rights to use TRIPS safeguards. Although the Doha broke new ground in guaranteeing Members' access to medical products, it did not solve all of the problems associated with intellectual property protection and public health. II. THE ACCESS PROBLEM AND INTELLECTUAL PROPERTY A number of new medicines that are vital for the survival of millions are already too costly for the vast majority of people in poor countries. In addition, investment in research and development (R&D) towards the health needs of people in developing countries has almost come to a standstill. Developing countries, where three-quarters of the world population lives, account for less than 10 percent of the global pharmaceutical market. The implementation of TRIPS is expected to have a further upward effect on drug prices, while increased R&D investment, despite higher levels of intellectual property protection, is not expected.3 One-third of the world population lacks access to the most basic essential drugs and, in the poorest parts of Africa and Asia, this figure climbs to one-half Access to treatment for diseases in developing countries is problematic either because the medicines are unaffordable, have become ineffective due to resistance, or are not sufficiently adapted to specific local conditions and constraints. Many factors contribute to the problem of limited access to essential medicines. Unavailability can be caused by logistical supply and storage problems, substandard drug quality, inappropriate selection of drugs, wasteful prescription and inappropriate use, inadequate production, and prohibitive prices. Despite the enormous burden of disease, drug discovery and development targeted at infectious and parasitic diseases in poor countries has virtually ground to a standstill because drug companies in developed and developing nations simply cannot recoup the cost of R&D for products to treat diseases that abound in developing countries. …
It is now well documented that substantial disparities exist in the quality and quantity of medical care received by minority Americans, especially those of African, Asian and Hispanic heritage. In addition, the special needs and responses to pharmaceutical treatment of these groups have been undervalued or ignored. This article reviews the genetic factors that underlie varying responses to medicines observed among different ethnic and racial groups. Pharmacogenetic research in the past few decades has uncovered significant differences among racial and ethnic groups in the metabolism, clinical effectiveness, and side-effect profiles of many clinically important drugs. These differences must be taken into account in the design of cost management policies such as formulary implementation, therapeutic substitution and step-care protocols. These programs should be broad and flexible enough to enable rational choices and individualized treatment for all patients, regardless of race or ethnic origin.
Medicines in Context: an Introduction.- The Transaction of Medicines.- Introductory Note.- Commercial Pharmaceutical Medicine and Medicalization: a Case Study from El Salvador.- Traditional Practitioners and Western Pharmaceuticals in Sri Lanka.- Medicines and Rural Health Services: an Experiment in the Dominican Republic.- Buying Drugs in Addis Ababa: a Quantitative Analysis.- `Casi como doctor': Pharmacists and their Clients in a Mexican Urban Context.- The Articulation of Formal and Informal Medicine Distribution in South Cameroon.- The Rise of the Modern Jamu Industry in Indonesia: a Preliminary Overview.- The Meaning of Medicines.- Introductory Note.- Culture and Pharmaceutics: Some Epistemological Observations of Pharmacological Systems in Ancient Europe and Medieval China.- The Use of Herbal and Biomedical Pharmaceuticals on Mauritius.- The Power of Medicines in East Africa.- Traditional Medication at Pregnancy and Childbirth in Madura, Indonesia.- The Reinterpretation and Distribution of Western Pharmaceuticals: an Example from the Mende of Sierra Leone.- Cultural Meanings of Oral Rehydration Salts in Jamaica.- Penicillin: an Ancient Ayurvedic Medicine.- Cultural Constructions of Efficacy.- Conclusion.- Pharmaceutical Anthropology: Perspectives for Research and Application.- List of Contributors.- Index of Names.- Index of Subjects.
Cocrystals, a long known but understudied class of crystalline solids, have attracted interest from crystal engineers and pharmaceutical scientists in the past decade and are now an integral part of the preformulation stage of drug development. This is largely because cocrystals that contain a drug molecule, pharmaceutical cocrystals, can modify physicochemical properties without the need for covalent modification of the drug molecule. This review presents a brief history of cocrystals before addressing recent advances in design, discovery and development of pharmaceutical cocrystals that have occurred since an earlier review published in 2004. We address four aspects of cocrystals: nomenclature; design using hydrogen-bonded supramolecular synthons; methods of discovery and synthesis; development of pharmaceutical cocrystals as drug products. Cocrystals can be classified into molecular cocrystals (MCCs) that contain only neutral components (coformers) and ionic cocrystals (ICCs), which are comprised of at least one ionic coformer that is a salt. That cocrystals, especially ICCs, offer much greater diversity in terms of composition and properties than single component crystal forms and are amenable to design makes them of continuing interest. Seven recent case studies that illustrate how pharmaceutical cocrystals can improve physicochemical properties and clinical performance of drug substances, including a recently approved drug product based upon an ICC, are presented.
Pulmonary administration route has been extensively exploited for the treatment of local lung diseases such as asthma, chronic obstructive pulmonary diseases and respiratory infections, and systemic diseases such as diabetes. Most inhaled medicines could be cleared rapidly from the lungs and their therapeutic effects are transit. The inhaled medicines with extended pulmonary exposure may not only improve the patient compliance by reducing the frequency of drug administration, but also enhance the clinical benefits to the patients with improved therapeutic outcomes. This article systematically reviews the physical and chemical strategies to extend the pulmonary exposure of the inhaled medicines. It starts with an introduction of various physiological and pathophysiological barriers for designing inhaled medicines with extended lung exposure, which is followed by recent advances in various strategies to overcome these barriers. Finally, the applications of the inhaled medicines with extended lung exposure for the treatment of various diseases and the safety concerns associated to various strategies to extend the pulmonary exposure of the inhaled medicines are summarized.
HIV/AIDS, tuberculosis, and malaria are the three major killers that account for 40 percent of mortality due to infectious diseases in the world. According to The World Health Report, 2004 (WHO), approximately 2.8, 1.6, and 1.3 million people died in 2002 respectively from AIDS, tuberculosis, and malaria. Further, a larger number of newly infected people have been added every year to the total of those living with these diseases, 5 million for HIV, from 8 to 9 million for tuberculosis, and 300 to 500 million for the malaria. What is important within the context of international development is that the majority of people infected by these diseases are concentrated in low-income countries. The burden of infectious diseases is a serious issue for many people in these countries and is considered a strong impediment to economic growth. The purpose of the book is to provide practical ways of stimulating research and development (R&D) for neglected diseases, in particular the three major killers mentioned above. Although patients living in low-income countries sorely need medicines, they usually cannot afford them. R&D activity for these medicines does not seem to be taken seriously by pharmaceutical companies. Within these circumstances, the authors examine reasons for the lack of R&D as well as various systems designed to deal with the problems associated with R&D incentives and access to medicines. From their analysis, they conclude that a commitment to purchasing vaccines could develop. Regarding this issue, Lanjouw (2002) has taken the position that since the existing patent system plays such an important role in innovations, it should be reformed in order to correspond to the actual circumstances of low-income countries. Thus, there is a difference between the two relative to whether the proposal applying to this problem is a substitute for or a complement to the existing patent system. In the past five years, discussion of this issue has become quite meaningful. Reflecting the upsurge of international public opinion, and with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), WTO members agreed to institute a more flexible policy regarding medicines for the three major killers from 2001 to 2003. Developing countries now have the right to produce drugs protected by the patent holder and to grant compulsory licenses to home manufacturers through this agreement. They can also import cheaper drugs from the countries that produce copies using compulsory licenses. While no country has used these rights so far, these amendments heighten the bargaining
The evolution of crystal engineering into a form of supramolecular synthesis is discussed in the context of problems and opportunities in the pharmaceutical industry. Specifically, it has become clear that a wide array of multiple component pharmaceutical phases, so called pharmaceutical co-crystals, can be rationally designed using crystal engineering, and the strategy affords new intellectual property and enhanced properties for pharmaceutical substances.
Beneath the beauty of coral reefs lies a hidden universe of microbes unlike anything scientists expected。 Each coral species supports its own specialized microbial partners, many of which have never been studied before。 These microbes produce a stunning variety of chemical compounds with potential uses in medicine and biotech
Patient acceptability of a medicinal product is a key aspect in the development and prescribing of medicines. Children and older adults differ in many aspects from the other age subsets of population and require particular considerations in medication acceptability. This review highlights the similarities and differences in these two age groups in relation to factors affecting acceptability of medicines. New and conventional formulations of medicines are considered regarding their appropriateness for use in children and older people. Aspects of a formulation that impact acceptability in these patient groups are discussed, including, for example, taste/smell/viscosity of a liquid and size/shape of a tablet. A better understanding of the acceptability of existing formulations highlights opportunities for the development of new and more acceptable medicines and facilitates safe and effective prescribing for the young and older populations.
Dendrimers are three-dimensional macromolecular structures originating from a central core molecule and surrounded by successive addition of branching layers (generation). These structures exhibit a high degree of molecular uniformity, narrow molecular weight distribution, tunable size and shape characteristics, as well as multivalency. Collectively, these physicochemical characteristics together with advancements in design of biodegradable backbones have conferred many applications to dendrimers in formulation science and nanopharmaceutical developments. These have included the use of dendrimers as pro-drugs and vehicles for solubilization, encapsulation, complexation, delivery, and site-specific targeting of small-molecule drugs, biopharmaceuticals, and contrast agents. We briefly review these advances, paying particular attention to attributes that make dendrimers versatile for drug formulation as well as challenging issues surrounding the future development of dendrimer-based medicines.
We surveyed faculty and residents from seven hospitals affiliated with three academic internal medicine training programs about their perceptions of the informational and service benefits vs the risks of ethical compromise involved in interactions with pharmaceutical sales representatives. Questionnaires were returned by 467 (81%) of 575 physicians surveyed. Residents and faculty generally had somewhat negative attitudes toward the educational and informational value of detailing activities at their institutions but indicated that representatives supported important conferences and speakers. Residents were more likely than faculty to perceive contacts with sales representatives as potentially influencing physician decision making. Sixty-seven percent of faculty and 77% of residents indicated that physicians could be compromised by accepting gifts. More than half of the physicians who suggested that such compromise was possible indicated that acceptance of gifts worth more than +100 from drug companies would be likely to compromise a physician's independence and objectivity. A majority of both faculty and house staff favored eliminating presentations by pharmaceutical representatives at their hospitals. Only 10% thought they had had sufficient training during medical school and residency regarding professional interaction with sales representatives.
What is 'pharmaceutics'? Design of dosage forms PART ONE: SCIENTIFIC PRINCIPLES OF DOSAGE FORM DESIGN *Dissolution and solubility *Properties of solutions *Rheology *Surface and interfacial phenomena *Disperse systems *Kinetics of product stability PART TWO: PARTICLE SCIENCE AND POWDER TECHNOLOGY *Solid-state properties *Particle size analysis *Particle size reduction *Particle size separation *Mixing *Powder flow. PART THREE: PHARMACEUTICAL MICROBIOLOGY AND STERILIZATION *Fundamentals of microbiology *Pharmaceutical applications of microbiological techniques *Action of physical and chemical agents on microorganisms *Principles of sterilization *Sterilization in practice PART FOUR: BIOPHARMACEUTICAL PRINCIPLES OF DRUG DELIVERY *Introduction to biopharmaceutics *Gastrointestinal tract - physiology and drug absorption *Bioavailability - physicochemical and dosage form factors *Assessment of biopharmaceutical properties *Dosage regimens PART FIVE: DOSAGE FORM DESIGN AND MANUFACTURE *Pharmaceutical preformulation *Solutions *Clarification *Suspensions and emulsions *Powders and granules *Granulation *Drying *Tablets and compaction *Modified-release peroral dosage forms *Coating of tablets and multiparticulates *Hard gelatin capsules *Soft gelatin capsules *Pulmonary drug delivery *Nasal drug delivery *Transdermal drug delivery *Wound dressings *Rectal and vaginal drug delivery *Delivery of pharmaceutical proteins *Packs and packaging *Microbial contamination, spoilage and preservation of medicines *Product stability and stability testing *Pharmaceutical plant design *Heat transfer and the properties and use of steam
Cocrystals are long known yet recently applied molecular entities. In the past decade, a significant potential has been demonstrated by these novel solids in terms of modifying the physicochemical and pharmacokinetic properties of drugs. Thus far, publications have outlined various aspects of cocrystals at the molecular level concentrating on their design, growing techniques, and physicochemical characterizations. However, to take cocrystals from bench to bedside, they have to be incorporated into suitable formulations notwithstanding that the attention paid to cocrystal formulations is so diminutive. This is the first systematic review based exclusively on cocrystals formulation. In this contribution, the impact of cocrystals on essential pharmaceutical properties is glanced at before shining the spotlight on cocrystals formulation. The findings suggest that preformulation characteristics play a significant role, however, after which a number of approaches are desired in order to develop successful cocrystal formulations. It further highlights the main hurdles encountered with cocrystals formulation and other challenges to the transformation of cocrystals into viable medicines to have the full picture. There are marketed cocrystal products now, and it can be said it is only a matter of time before cocrystals are added to the main selection toolbox alongside salts for developing medicinal products.