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This is a book for practitioners working in community-based healthcare as well as educators of future practitioners and researchers exploring this practice field and for people with chronic disabilities and their families and carers. The book invites readers to re-think and re-shape the way that community-based healthcare is practised by practitioners and experienced/engaged with by clients/patients and their families and other carers. Based on a PhD study of therapeutic relationships in community healthcare settings in NSW, Australia, and on real-life experiences of practitioners, clients and clients' families and care givers, this book paints a rich picture of the lived experiences of these participants in community-based healthcare. It examines the issues and challenges they face and the ways they deal with these. Key themes identified across the book are: the value and nature of relationships in this unique healthcare setting, the importance of time and using it well, the way good teamwork facilitates good community-based, patient-centred healthcare, balancing autonomy and equality with healthcare quality, practice wisdom embodied in healthcare, and ways of improving healthcare in clients' own homes -- Provided by the publisher.

Independent, science-based regulation of medical products is a critical part of ensuring quality healthcare and, when conducted in a transparent, science-based, efficient, accountable, and predictable manner, it can help ensure access to quality products that patients need and can have a very positive impact on public health. [...]African countries must contend with 75% of the world’s HIV/AIDS cases and 90% of its malaria deaths, and access to quality versions of the newest and most effective medicines is key in treating these infections [8], as well as in disease control strategies. The consortium included regulatory and political bodies (AUDA-NEPAD, PAP, the African Union Commission, the Heads of NMRAs, the Joint United Nations Programme on HIV/AIDS), the World Bank, technical partners (WHO, the Swiss Agency for Therapeutic Products [Swissmedic]), and donors (the Bill & Melinda Gates Foundation, the Clinton Health Access Initiative, the UK Department for International Development) [12]. At this time, there was only sufficient funding for the consortium to support one pilot project. [...]the consortium decided to solicit proposals from each of the RECs and fund the most promising plan for MRH over the next 5 years.

(Drug-induced extrapyramidal side effects are movement disorders with acute and long-term symptoms, including dystonia, akathisia, parkinsonism, bradykinesia, tremor, and tardive dyskinesia.) Without the help of the eight sub-Saharan African countries that submitted reports to VigiBase, it is unclear whether the association between the medicine combination and this adverse event would have been detected. Because of the countries’ vigilance, healthcare providers can now be alert for these reactions and treat them promptly. Unfortunately, due to a number of factors, including inadequate legal framework and infrastructure, limited financial resources, and the number and competency of staff available to support pharmacovigilance systems, many African countries struggle to gather and report information about suspected adverse events, which is key for monitoring the safety of medicines on the market. CRO, contract research organization; EAC, East African Community; GMP, good manufacturing practice; ISO, International Organization for Standardization; IVD, in vitro diagnostic; JA, joint assessment; MRH, Medicines Regulatory Harmonization; NMRA, national medicines regulatory authority; PV, pharmacovigilance; RTO, regional technical officer; WHO, World Health Organization. https://doi.org/10.1371/journal.pmed.1003129.g001 To ensure that all the program’s priorities are being championed, each NMRA now has one RTO, each of whom specializes in a different area. [...]once a product has been recommended through the joint assessment process, the RTO will follow up with NMRAs to ensure that national registrations proceed in a timely manner.

Summary points * Substandard and/or falsified medical products may result in treatment failure and/or death. * The capacity to regulate medical products is key for ensuring the quality, safety, and efficacy of medical products circulating in a market. * The experience of the East African Community, during its piloting of the Medicines Regulatory Harmonization initiative, serves as a lesson for scaling up the African Medicines Regulatory Harmonization Program across the continent. * Currently, the East African Community’s Medicines Regulatory Harmonization initiative is poised to transition from a donor-funded pilot project into a self-sustaining, permanent feature of the African regulatory landscape. * Government, partner, and public support is needed for strong systems to regulate medicines in the East African Community and elsewhere in the world. With support from partners including the AU Development Agency–New Partnership for Africa’s Development, World Bank, World Health Organization, Swiss Agency for Therapeutic Products (Swissmedic), United Kingdom Department for International Development, and Bill & Melinda Gates Foundation, the initiative provided the needed technical, financial, and political advocacy support. The importance of regulatory harmonization and cooperation in ensuring access to quality versions of essential medicines is well recognized [13]. [...]in this Special Collection of 5 articles, we describe the EAC MRH initiative from its beginning through its plans for the future. Sharing information about the EAC MRH initiative is also important because it represents the first step on a path leading toward continent-wide, coordinated regulation of medicines. Since the EAC MRH initiative started, a number of other regional economic communities have launched their own regional harmonization initiatives.

According to the World Health Organization (WHO) [1], NMRAs contribute to promoting and protecting public health and safety by ensuring that. * medicines are of the required quality, safety, and efficacy; * health professionals and patients have the necessary information to enable them to use medicines rationally; * medicines are appropriately manufactured, stored, distributed, and dispensed; * illegal manufacturing and trade are detected and adequately sanctioned; * promotion and advertising are fair, balanced, and aimed at rational drug use; and * access to medicines is not hindered by unjustified regulatory work. Afterward, the medicines were registered by Kenya and Uganda (although the medicines were eligible for registration in all EAC countries, the manufacturer decided to register them in only 3). Because of this new regional approach to product assessment, these medicines were available in EAC countries sooner than they would have been otherwise. [...]the EAC MRH initiative was expected to identify a funding mechanism that would allow it to sustain and broaden its regulatory activities after the catalytic donor support available for the first 5 years expired. The initiative’s Medicines Evaluation & Registration Working Group, led by Tanzania’s NMRA, created this CTD as part of the program’s larger mandate of harmonizing technical requirements, standards, and standard operating procedures (SOPs) for medicines assessment and registration across the region [8]. Because the EAC’s CTD is based on the formats used by ICH and the WHO’s Prequalification Programme, EAC Partner States can easily leverage dossiers previously submitted to other regulatory authorities, such as the WHO, US Food and Drug Administration, or European Medicines Agency.

Background The most prevalent neglected tropical diseases are treated through blanket drug distribution that is reliant on lay community medicine distributors (CMDs). Yet, treatment rates achieved by CMDs vary widely and it is not known which CMDs treat the most people. Methods In Mayuge District, Uganda, we tracked 6779 individuals (aged 1+ years) in 1238 households across 31 villages. Routine, community-based mass drug administration (MDA) was implemented for schistosomiasis, lymphatic filariasis, and soil-transmitted helminths. For each CMD, the percentage of eligible individuals treated (offered and ingested medicines) with at least one drug of praziquantel, albendazole, or ivermectin was examined. CMD attributes (more than 25) were measured, ranging from altruistic tendencies to socioeconomic characteristics to MDA-specific variables. The predictors of treatment rates achieved by CMDs were selected with least absolute shrinkage and selection operators and then analyzed in ordinary least squares regression with standard errors clustered by village. The influences of participant compliance and the ordering of drugs offered also were examined for the treatment rates achieved by CMDs. Results Overall, only 44.89% (3043/6779) of eligible individuals were treated with at least one drug. Treatment rates varied amongst CMDs from 0% to 84.25%. Treatment rate increases were associated ( p value< 0.05) with CMDs who displayed altruistic biases towards their friends (13.88%), had friends who helped with MDA (8.43%), were male (11.96%), worked as fishermen/fishmongers (14.93%), and used protected drinking water sources (13.43%). Only 0.24% (16/6779) of all eligible individuals were noncompliant by refusing to ingest all offered drugs. Distributing praziquantel first was strongly, positively correlated ( p value < 0.0001) with treatment rates for albendazole and ivermectin. Conclusions These findings profile CMDs who treat the most people during routine MDA. Criteria currently used to select CMDs—community-wide meetings, educational attainment, age, years as a CMD, etc.—were uninformative. Participant noncompliance and the provision of praziquantel before albendazole and ivermectin did not negatively impact treatment rates achieved by CMDs. Engaging CMD friend groups with MDA, selecting CMDs who practise good preventative health behaviours, and including CMDs with high-risk occupations for endemic infections may improve MDA treatment rates. Evidence-based guidelines are needed to improve the monitoring, selection, and replacement of CMDs during MDA.

Emergency medical services (EMS) programs have been using point-of-care testing (POCT) for more than 20 years. However, only a handful of reports have been published in all of that time on POCT practices in field settings. To provide an overview of POCT practices and failure modes in 3 of Alberta's EMS programs, and to propose risk-mitigation strategies for reducing or eliminating these failure modes. Details about POCT practices, failure modes, and risk-mitigation strategies were gathered through (1) conversations with personnel, (2) in-person tours of EMS bases, (3) accompaniment of EMS personnel on missions, (4) internet searches for publicly available information, and (5) a review of laboratory documents. Practices were most standardized and robust in the community paramedicine program (single service provider, full laboratory oversight), and least standardized and robust in the air ambulance program (4 service providers, limited laboratory oversight). Common failure modes across all 3 programs included device inoperability due to cold weather, analytical validation procedures that failed to consider the unique challenges of EMS settings, and a lack of real-time electronic transmission of results into the health care record. A provincial framework for POCT in EMS programs is desirable. Such a framework should include appropriate funding models, laboratory oversight of POCT, and relevant expertise on POCT in EMS settings. The framework should also incorporate specific guidance on quality standards that are needed to address the unique challenges of performing POCT in field settings.