An Overview of Progress in the International Regulation of the Pharmaceutical Industry

[Excerpt] “The pharmaceutical industry, a significant source of healthcare throughout the world, has several features that distinguish it from the rest of the health industry. In the last half-century, new technology, better technological know-how, and overall economic growth have led to widespread and rapid growth in the pharmaceutical sector. Advancements in pharmaceutical research and development have led to the production of drugs that can routinely combat afflictions that, only years ago, were untreatable or even fatal. Since 1970, the average share of Gross Domestic Product (GDP) on pharmaceutical goods has increased in most Organization for Economic Cooperation and Development (OECD) countries by approximately 50%, meaning that pharmaceutical expenditure has increased on average 1.5% more per year than GDP growth. Given that access to health care is fundamental to developed society and that pharmaceutical goods are a significant source of healthcare, drugs should be accessible to everyone across the world. However, universal accessibility to drugs is not an easy feat. As nations work with their pharmaceutical industries to provide the best possible access to drugs, they must do so on limited budgets and while maintaining proper incentives for pharmaceutical companies to continue to innovate. These conflicting objectives are problems unique to the pharmaceutical industry and critical to its successful future. In the European Union (EU), major steps are being made to balance these objectives through the establishment of a Single Market for Pharmaceuticals. As stated in a Commission Communication on the single market in pharmaceuticals, “The purpose of the completion of the Single Market in Pharmaceuticals is not just to provide an environment which is favorable for pharmaceutical innovation and industrial development, it is also to improve consumer choices in pharmaceuticals of the required quality, safety and efficacy, at an affordable cost.” The aim of this note is to present an overview of the major factors that are currently shaping and effecting international trade in the international pharmaceutical industry, and of how these factors contribute to the EU\u27s progression towards a single market. Through outlining the present status of the industry, we hope to facilitate the making of future decisions to reach a better balance between industry innovation and healthcare accessibility.

Processing-Induced Disorder in Pharmaceutical Materials

This chapter focuses on the major types of pharmaceutical processing methods that have been widely reported to produce disordered material either intentionally or unintentionally. Milling is one of the most frequently used unit operations used by the pharmaceutical industry for reducing the particle size of solids. Thermal processing techniques are mainly used for controlling or improving the release and the subsequent bioavailability of an active pharmaceutical ingredient (API). Techniques such as melt-mixing, spray-congealing, sintering, melt-granulation, and hot-melt extrusion (HME) have developed and evolved rapidly for large-scale pharmaceutical production. Solvent-evaporation-based methods are important processing techniques for both raw materials, such as crystallization of the raw drug, and formulation manufacturing in the pharmaceutical industry. The chapter discusses the processing that can potentially induce the formation of the disordered state during the manufacture of formulations. The widely used solvent-evaporation-based processing techniques in pharmaceutical formulation production include spray-drying, freeze-drying, film casting, and film coating

Methodology for Assessing the Logistics Potential of the Foreign Economic Activity of a Pharmaceutical Company

The aim of the article is to determine the essence of the logistics potential of a foreign trade activity of a pharmaceutical enterprise and justify the methods for determining it.The materials used in the study include statistical data of the investigated pharmaceutical enterprises, namely JSC FF “Darnitsa”, PJSC NPC “Borschagovsky Chemical and Pharmaceutical Plant”, PJSC “Pharmak”, LLC “FC Zdorovia” and JSC “Lekhim-Kharkiv”. The study used methods of analysis and synthesis, generalization, content analysis, questionnaires and methods for assessing potential. The questionnaire was used to select indicators that should be part of the logistics potential of a foreign trade activity of a pharmaceutical enterprise.The experts were 100 leading specialists of pharmaceutical companies. They are all involved in foreign economic activity. Experts are gender–divided into women (73 %), men (27 %); by age: up to 25 years – 8 %, 25–35 years – 14 %, 35–45 years – 27 %, 45–55 years – 36 %, over 55 years – 15 %; by experience: up to 5 years – 11 %, 5–10 years – 15 %, 10–20 years – 32 %, 20–30 years – 36 %, over 30 years – 6 %. The experts\u27 conclusions are valid, the coefficient of concordance is 0.86, and the Pearson test exceeds the table value.The essence of the definition of "potential of logistics of pharmaceutical enterprise\u27s foreign trade activity" is investigated. The types of logistics potential of foreign economic activity and indicators that are appropriate to use for determining the level of development of the logistic potential in foreign economic activity are offered.The potential of logistics of foreign trade activities of pharmaceutical enterprises consists of the potentials of logistics in the field of export and import. The system of indicators for measuring the logistics potential of a foreign trade activity of a pharmaceutical enterprise contains indicators selected through content analysis and questionnaires.The method of estimation of logistics potential in foreign economic activity of pharmaceutical enterprise is offered

Pharmaceuticals active compounds in the aquatic environment: a review

Pharmaceutical active substances utilised to treat human and animal diseases can launch into the environment through effluents from wastewater treatment plants and direct disposal of pharmaceutical compounds. Some of these compounds arrive in the environment as a parent compound or as active/inactive metabolites. Owing to their pharmacological action, their conceptions in the environment are significant, and thus this chapter reviews the understanding of the presence of pharmaceutical compounds in the environment

The rise of companies from emerging markets in global health governance: opportunities and challenges

The article analyses the involvement of pharmaceutical companies from emerging markets in global health governance. It finds that they play a central role as low-cost suppliers of medicines and vaccines and, increasingly, new technologies. In so doing, pharmaceutical companies from emerging markets have facilitated the implementation of a key goal of global health policy: widening access to pharmaceutical treatment and prevention. Yet, looking closer at the political economy underlying their involvement, the article exposes a tension between this policy goal and the political economy of pharmaceutical development and production. By declaring access to pharmaceuticals a goal of global health policy, governments and global health partnerships have made themselves dependent on pharmaceutical companies to supply them. Moreover, to provide pharmaceutical treatment and prevention at the global level, they depend on companies to supply medicines and vaccines at extremely low prices. Yet, the development and production of pharmaceuticals is organized around commercial incentives that are at odds with the prices required. The increasing involvement of low-cost suppliers from emerging markets mitigates this tension in the short run. In the long run, this tension endangers the sustainability of global access policies and may even undermine some of the successes already achieved

After Heparin: Protecting Consumers From the Risks of Substandard and Counterfeit Drugs

Based on case studies, examines globalization and quality management trends in pharmaceutical manufacturing, barriers to Federal Drug Administration oversight, and the security of pharmaceutical distribution. Makes policy recommendations to ensure safety

Pharmaceutical care for elderly patients shared between community pharmacists and general practitioners: a randomised evaluation. RESPECT (Randomised Evaluation of Shared Prescribing for Elderly people in the Community over Time) [ISRCTN16932128]

Background: This trial aims to investigate the effectiveness and cost implications of 'pharmaceutical care' provided by community pharmacists to elderly patients in the community. As the UK government has proposed that by 2004 pharmaceutical care services should extend nationwide, this provides an opportunity to evaluate the effect of pharmaceutical care for the elderly. Design: The trial design is a randomised multiple interrupted time series. We aim to recruit 700 patients from about 20 general practices, each associated with about three community pharmacies, from each of the five Primary Care Trusts in North and East Yorkshire. We shall randomise the five resulting groups of practices, pharmacies and patients to begin pharmaceutical care in five successive phases. All five will act as controls until they receive the intervention in a random sequence. Until they receive training community pharmacists will provide their usual dispensing services and so act as controls. The community pharmacists and general practitioners will receive training in pharmaceutical care for the elderly. Once trained, community pharmacists will meet recruited patients, either in their pharmacies (in a consultation room or dispensary to preserve confidentiality) or at home. They will identify drug-related issues/problems, and design a pharmaceutical care plan in conjunction with both the GP and the patient. they will implement monitor, and update this plan monthly. the primary outcome measure is the 'Medication Appropriateness Index'. Secondary measures include adverse events, quality of life, and patient knowledge and compliance. We shall also investigate the cost of pharmaceutical care to the NHS, to patients and to society as a whole

The Workforce Needs of New Jersey's Pharmaceutical and Medical Technology Industry

This report is based on an online survey conducted in spring 2006 of pharmaceutical and medical technology companies in New Jersey. It identifies the current and future workforce needs of the pharmaceutical and medical technology industry in New Jersey

pharmaceutical care

pharmaceutical car