Pharmacovigilance of herbal medicines

Pharmacovigilance is essential for developing reliable information on the safety of herbal medicines as used in Europe and the US. The existing systems were developed for synthetic medicines and require some modification to address the specific differences of medicinal herbs. Traditional medicine from many different cultures is used in Europe and the US which adds to the complexities and difficulties of even basic questions such as herb naming systems and chemical variability. Allied to this also is the perception that a ‘natural’ or herbal product must be safe simply because it is not synthetic which means that the safety element of monitoring for such medicines can be overlooked because of the tag associated with such products. Cooperation between orthodox physicians and traditional practitioners is needed to bring together the full case details. Independent scientific assistance on toxicological investigation, botanical verification can be invaluable for full evaluation of any case report. Systematic pharmacovigilance is essential to build up reliable information on the safety of herbal medicines for the development of appropriate guidelines for safe effective use.

Care homes’ use of medicines study: prevalence, causes and potential harm of medication errors in care homes for older people

Introduction: Care home residents are at particular risk from medication errors, and our objective was to determine the prevalence and potential harm of prescribing, monitoring, dispensing and administration errors in UK care homes, and to identify their causes. Methods: A prospective study of a random sample of residents within a purposive sample of homes in three areas. Errors were identified by patient interview, note review, observation of practice and examination of dispensed items. Causes were understood by observation and from theoretically framed interviews with home staff, doctors and pharmacists. Potential harm from errors was assessed by expert judgement. Results: The 256 residents recruited in 55 homes were taking a mean of 8.0 medicines. One hundred and seventy-eight (69.5%) of residents had one or more errors. The mean number per resident was 1.9 errors. The mean potential harm from prescribing, monitoring, administration and dispensing errors was 2.6, 3.7, 2.1 and 2.0 (0 = no harm, 10 = death), respectively. Contributing factors from the 89 interviews included doctors who were not accessible, did not know the residents and lacked information in homes when prescribing; home staff’s high workload, lack of medicines training and drug round interruptions; lack of team work among home, practice and pharmacy; inefficient ordering systems; inaccurate medicine records and prevalence of verbal communication; and difficult to fill (and check) medication administration systems. Conclusions: That two thirds of residents were exposed to one or more medication errors is of concern. The will to improve exists, but there is a lack of overall responsibility. Action is required from all concerned.

Cancer patients taking herbal medicines: a review of clinical purposes, associated factors, and perceptions of benefit or harm

Ethnopharmacological relevance: Cancer patients in all cultures are high consumers of herbal medicines (HMs) usually as part of a regime consisting of several complementary and alternative medicine (CAM) modalities, but the type of patient, the reasons for choosing such HM-CAM regimes, and the benefits they perceive from taking them are poorly understood. There are also concerns that local information may be ignored due to language issues. This study investigates aspects of HM-CAM use in cancer patients using two different abstracting sources: Medline, which contains only peer-reviewed studies from SCI journals, and in order to explore whether further data may be available regionally, the Thai national databases of HM and CAM were searched as an example. Materials and methods: the international and Thai language databases were searched separately to identify relevant studies, using key words chosen to include HM use in all traditions. Analysis of these was undertaken to identify socio-demographic and clinical factors, as well as sources of information, which may inform the decision to use HMs. Results: Medline yielded 5,638 records, with 49 papers fitting the criteria for review. The Thai databases yielded 155, with none relevant for review. Factors associated with HM-CAM usage were: a younger age, higher education or economic status, multiple chemotherapy treatment, late stage of disease. The most common purposes for using HM-CAM cited by patients were to improve physical symptoms, support emotional health, stimulate the immune system, improve quality of life, and relieve side-effects of conventional treatment. Conclusions: Several indicators were identified for cancer patients who are most likely to take HM-CAM. However, interpreting the clinical reasons why patients decide to use HM-CAM is hampered by a lack of standard terminology and thematic coding, because patients' own descriptions are too variable and overlapping for meaningful comparison. Nevertheless, fears that the results of local studies published regionally are being missed, at least in the case of Thailand, appeared to be unfounded.

Medicines and other Resources Utilized in Order to Cope Infants Diseases in the Family Daily Life: a qualitative study

Medicines and other Resources Utilized in Order to Cope Infants Diseases in the Family Daily Life: a qualitative study. The study proposes to investigate the use of medications, medicinal plants and other therapeutic resources to cope infants diseases in the domestic realm in an urban area. The ethnographic research method was utilized as referential, guiding the study for 10 months with 20 fortnight meetings in the domicile of 15 families. The study followed up 180 episodes of disease, 74,5% were treated, in a first instance, at home, resulting in the use of 212 therapeutic resources. The main type of therapeutic resource utilized was industrialized medicines, differing considerably from its clinic recommendations. The realm of the health services was more mobilized as a second treatment option. In the community realm, treatment of diseases known from the popular culture was performed via blessings and prayers. The families use medicines as cultural practices and the acceptance of some type of treatment depends on the expectations and experiences of the family.

Older people's experience of utilisation and administration of medicines in a health- and social care context

BACKGROUND: People living at home who lack ability to manage their medicine are entitled to assistance to improve adherence provided by a home care assistant employed by social care. AIM: The aim was to describe how older people with chronic diseases, living at home, experience the use and assistance of administration of medicines in the context of social care. DESIGN: A qualitative descriptive study. METHODS: Ten participants (age 65+) living at home were interviewed in the participants' own homes. Latent content analysis was used. FINDINGS: The assistance eases daily life with regard to practical matters and increases adherence to a medicine regimen. There were mixed feelings about being dependent on assistance; it interferes with self-sufficiency at a time of health transition. Participants were balancing empowerment and a dubious perception of the home care assistants' knowledge of medicine and safety. Physicians' and district nurses' professional knowledge was a safety guarantee for the medicine process. CONCLUSIONS: Assistance eases daily life and medicine regimen adherence. Dependence on assistance may affect self-sufficiency. Perceived safety varied relating to home care assistants' knowledge of medicine. RELEVANCE TO CLINICAL PRACTICE: A well-functioning medicine assistance is crucial to enable older people to remain at home. A person-centred approach to health- and social care delivery is efficient and improve outcome for the recipient of care.

Pharmaceutical patent bargains: the Brazilian experience

In the backdrop of the strict patent regime flatly adopted by the World Trade Organization (WTO) for all countries, a few countries constantly challenge this system through aggressive patent bargains. Within the pharmaceutical sector, noticeably, some countries now threaten to issue or otherwise actually issue compulsory licenses that may sway large pharmaceutical companies into selling drugs with large discounts or into granting voluntary licenses domestically. That is conspicuously the negotiation strategy adopted by Brazil in its negotiations with big international pharmaceutical companies.This paper explains Brazil’s aggressive bargaining approach based on an analysis of two aspects of its political economy. The first has to do with the international context of patent bargaining in the post-WTO era. Accordingly, the existence of large and fast growing domestic markets position countries such as Brazil as strategic destinations for Foreign Direct Investment (FDI) and trade. Together with an absence of a propensity to innovate in pharmaceutical products, these conditions boost Brazil’s bargaining power for issuing compulsory licenses over pharmaceutical products. The second aspect is related to political economy dynamics inside Brazil. Accordingly, the political framework in Brazil undermines long-term policies and favors short-sighted ones also vis-a-vis R&D investments in the pharmaceutical industry. This remains true regardless of the strictness of the patent regime in place. The lesson of Brazil is relevant arguably for other more powerful developing countries which presently examine Brazil's approach while further challenging the WTO's strict patent policy for the future.

Understanding e-government technology transfer: evidence from the transfer of a patent management system from EPO to INPI

Drawing upon Brazilian experience, this research explores some of the key issues to be addressed in using e-government technical cooperation designed to enhance service provision of Patent Offices in developing countries. While the development of software applications is often seen merely as a technical engineering exercise, localization and adaptation are context bounded matters that are characterized by many entanglements of human and non-humans. In this work, technical, legal and policy implications of technical cooperation are also discussed in a complex and dynamic implementation environment characterized by the influence of powerful hidden agendas associated with the arena of intellectual property (IP), which are shaped by recent technological, economic and social developments in our current knowledge-based economy. This research employs two different theoretical lenses to examine the same case, which consists of transfer of a Patent Management System (PMS) from the European Patent Office (EPO) to the Brazilian Patent Office that is locally named ‘Instituto Nacional da Propriedade Industrial’ (INPI). Fundamentally, we have opted for a multi-paper thesis comprising an introduction, three scientific articles and a concluding chapter that discusses and compares the insights obtained from each article. The first article is dedicated to present an extensive literature review on e-government and technology transfer. This review allowed the proposition on an integrative meta-model of e-government technology transfer, which is named E-government Transfer Model (ETM). Subsequently, in the second article, we present Actor-Network Theory (ANT) as a framework for understanding the processes of transferring e-government technologies from Patent Offices in developed countries to Patent Offices in developing countries. Overall, ANT is seen as having a potentially wide area of application and being a promising theoretical vehicle in IS research to carry out a social analysis of messy and heterogeneous processes that drive technical change. Drawing particularly on the works of Bruno Latour, Michel Callon and John Law, this work applies this theory to a longitudinal study of the management information systems supporting the Brazilian Patent Office restructuration plan that involved the implementation of a European Patent Management System in Brazil. Based upon the ANT elements, we follow the actors to identify and understand patterns of group formation associated with the technical cooperation between the Brazilian Patent Office (INPI) and the European Patent Office (EPO). Therefore, this research explores the intricate relationships and interactions between human and non-human actors in their attempts to construct various network alliances, thereby demonstrating that technologies embodies compromise. Finally, the third article applies ETM model as a heuristic frame to examine the same case previously studied from an ANT perspective. We have found evidence that ETM has strong heuristic qualities that can guide practitioners who are engaged in the transfer of e-government systems from developed to developing countries. The successful implementation of e-government projects in developing countries is important to stimulate economic growth and, as a result, we need to understand the processes through which such projects are being implemented and succeed. Here, we attempt to improve understanding on the development and stabilization of a complex social-technical system in the arena of intellectual property. Our preliminary findings suggest that e-government technology transfer is an inherently political process and that successful outcomes require continuous incremental actions and improvisations to address the ongoing issues as they emerge.

Why is patent production so comparatively low at Petrobras?

As a latecomer firm, Petrobras’ innovation progress has previously been measured in terms of its productive capacity, capability accumulation, and more recently in terms of its strategic R&D and new product development. Patents are an acceptable proxy for innovation, especially for complex innovations such as biofuels and deepwater oil exploration & production, and this study evaluates Petrobras’ patent intensity relative to Shell and ExxonMobil for the years 2008–2012. The study found that while Petrobras may be a world-leader in deepwater E&P, its patent activities and portfolio are not competitive with its peers. This low patent intensity (and, by proxy, innovation) of Petrobras’ is explained by past and present institutional, cultural, and firm-specific factors.

Diagnosis of Public Programs focused on Herbal Medicines in Brazil

The present study is aimed to diagnose the current public programs focused on herbal medicine in Brazil where the following results can be observed. The main purpose of implementation of these programs was the demand of the users of medicinal plants and herbal medicines. The initiative of the implementation of these programs was related to the managers (58%). The difficulties in this implementation were due to lack of funding (90%) of the programs. In 80% of the programs, the physicians did not adhere to herbal medicine services due to lack of knowledge in the subject. Training courses were proposed (70%) to increase the adhesion of prescribers to the system. Some municipalities use information obtained from patients to assess the therapeutic efficiency of medicinal plants and herbal medicines. of the programs underway, cultivation of medicinal plants was observed in 50%, and 67% of the programs adopted quality control. In most programs, this control is not performed in accordance with the legal requirements.