Does the development of new medicinal products in the European Union address global and regional health concerns?

<p>Abstract</p> <p>Background</p> <p>Since 1995, approval for many new medicinal products has been obtained through a centralized procedure in the European Union. In recent years, the use of summary measures of population health has become widespread. We investigated whether efforts to develop innovative medicines are focusing on the most relevant conditions from a global public health perspective.</p> <p>Methods</p> <p>We reviewed the information on new medicinal products approved by centralized procedure from 1995 to 2009, information that is available to the public in the European Commission Register of medicinal products and the European Public Assessment Reports from the European Medicines Agency. Morbidity and mortality data were included for each disease group, according to the Global Burden of Disease project. We evaluated the association between authorized medicinal products and burden of disease measures based on disability-adjusted life years (DALYs) in the European Union and worldwide.</p> <p>Results</p> <p>We considered 520 marketing authorizations for medicinal products and 338 active ingredients. New authorizations were seen to increase over the period analyzed. There was a positive, high correlation between DALYs and new medicinal product development (ρ = 0.619, p = 0.005) in the European Union, and a moderate correlation for middle-low-income countries (ρ = 0.497, p = 0.030) and worldwide (ρ = 0.490, p = 0.033). The most neglected conditions at the European level (based on their attributable health losses) were neuropsychiatric diseases, cardiovascular diseases, respiratory diseases, sense organ conditions, and digestive diseases, while globally, they were perinatal conditions, respiratory infections, sense organ conditions, respiratory diseases, and digestive diseases.</p> <p>Conclusions</p> <p>We find that the development of new medicinal products is higher for some diseases than others. Pharmaceutical industry leaders and policymakers are invited to consider the implications of this imbalance by establishing work plans that allow for the setting of future priorities from a public health perspective.</p

Stakeholders' Participation in Planning and Priority Setting in the Context of a Decentralised Health Care system: the case of prevention of mother to child Transmission of HIV Programme in Tanzania.

In Tanzania, decentralisation processes and reforms in the health sector aimed at improving planning and accountability in the sector. As a result, districts were given authority to undertake local planning and set priorities as well as allocate resources fairly to promote the health of a population with varied needs. Nevertheless, priority setting in the health care service has remained a challenge. The study assessed the priority setting processes in the planning of the prevention of mother to child transmission of HIV (PMTCT) programme at the district level in Tanzania. This qualitative study was conducted in Mbarali district, south-western Tanzania. The study applied in-depth interviews and focus group discussions in the data collection. Informants included members of the Council Health Management Team, regional PMTCT managers and health facility providers. Two plans were reported where PMTCT activities could be accommodated; the Comprehensive Council Health Plan and the Regional PMTCT Plan that was donor funded. As donors had their own globally defined priorities, it proved difficult for district and regional managers to accommodate locally defined PMTCT priorities in these plans. As a result few of these were funded. Guidelines and main priority areas of the Ministry of Health and Social Welfare (MoHSW) also impacted on the ability of the districts and regions to act, undermining the effectiveness of the decentralisation policy in the health sector. The challenges in the priority setting processes revealed within the PMTCT initiative indicate substantial weaknesses in implementing the Tanzania decentralisation policy. There is an urgent need to revive the strategies and aims of the decentralisation policy at all levels of the health care system with a view to improving health service delivery

Methods for economic evaluation of a factorial-design cluster randomised controlled trial of a nutrition supplement and an exercise programme among healthy older people living in Santiago, Chile: the CENEX study

BACKGROUND: In an effort to promote healthy ageing and preserve health and function, the government of Chile has formulated a package of actions into the Programme for Complementary Food in Older People (Programa de Alimentación Complementaria para el Adulto Mayor - PACAM). The CENEX study was designed to evaluate the impact, cost and cost-effectiveness of the PACAM and a specially designed exercise programme on pneumonia incidence, walking capacity and body mass index in healthy older people living in low- to medium-socio-economic status areas of Santiago. The purpose of this paper is to describe in detail the methods that will be used to estimate the incremental costs and cost-effectiveness of the interventions. METHODS AND DESIGN: The base-case analysis will adopt a societal perspective, including the direct medical and non-medical costs borne by the government and patients. The cost of the interventions will be calculated by the ingredients approach, in which the total quantities of goods and services actually employed in applying the interventions will be estimated, and multiplied by their respective unit prices. Relevant information on costs of interventions will be obtained mainly from administrative records. The costs borne by patients will be collected via exit and telephone interviews. An annual discount rate of 8% will be used, consistent with the rate recommended by the Government of Chile. All costs will be converted from Chilean Peso to US dollars with the 2007 average period exchange rate of US$1 = 522.37 Chilean Peso. To test the robustness of model results, we will vary the assumptions over a plausible range in sensitivity analyses. DISCUSSION: The protocol described here indicates our intent to conduct an economic evaluation alongside the CENEX study. It provides a detailed and transparent statement of planned data collection methods and analyses. TRIAL REGISTRATION: ISRCTN48153354

An assessment of the eye care workforce in Enugu State, south-eastern Nigeria

<p>Abstract</p> <p>Background</p> <p>The availability and distribution of an appropriate eye care workforce are fundamental to reaching the goals of "VISION 2020: The right to sight", the global initiative for the elimination of avoidable blindness launched jointly by the World Health Organization and the International Agency for the Prevention of Blindness with an international membership of nongovernmental organizations, professional associations, eye care institutions and corporations. Periodic evaluation of these parameters is important in the journey towards achieving these goals. The objectives of the study were to determine the availability and distribution of human resources for eye care delivery in Enugu Urban, south-eastern Nigeria.</p> <p>Methods</p> <p>The study was designed as a cross-sectional descriptive survey, the setting for which was all public and privately owned eye care facilities in Enugu Urban, Enugu State, south-eastern Nigeria, in October 2006. The health map of Enugu Urban and the hospital register of the Public Health Department of the Enugu State Ministry of Health were used to identify the eye health care facilities in Enugu Urban. A structured, pretested, researcher-administered questionnaire was used to capture data on cadre and distribution of the eye care personnel in these facilities.</p> <p>Relevant population data were obtained from the Enugu Regional Office of the National Population Commission. Descriptive statistical analysis was used to generate percentages and proportions. Eye care personnel-to-population ratios were calculated and compared to World Health Organization recommendations.</p> <p>Results</p> <p>Out of Enugu State's population of three million, Enugu Urban accounts for 22%. The population of Enugu Urban is distributed between the three-component Local Government Areas comprising Enugu North (31%), Enugu South (30%) and Enugu East (39%). There are 45 eye care facilities (public: 31 (69%); private: 14 (31%)) employing 252 eye care workers (public: 226 (90%); private: 26 (10%)) aged 18 to 63 (mean = 36.1 years, SD = 2 years) comprising males (36: 14%) and females (216: 86%), giving a male-to-female sex ratio of 1:6. The available eye care workforce is unevenly distributed between Enugu North (128: 51%), Enugu South (65: 26%) and Enugu East (59: 23%) Local Government Areas.</p> <p>Conclusion</p> <p>Using broad and crude World Health Organization standards for minimum provider-to-population ratios, there is a sufficient eye care workforce in Enugu Urban. However, the maldistribution of the workforce creates a major barrier to uptake of eye care services. Policy modifications could reverse this maldistribution.</p

Early cancer detection among rural and urban californians

BACKGROUND: Since the stage of cancer detection generally predicts future mortality rates, a key cancer control strategy is to increase the proportion of cancers found in the early stage. This study compared stage of detection for members of rural and urban communities to determine whether disparities were present. METHODS: The California Cancer Registry (CCR), a total population based cancer registry, was used to examine the proportion of early stage presentation for patients with breast, melanoma, and colon cancer from 1988 to 2003. Cancer stage at time of detection for these cancers was compared for rural and urban areas. RESULTS: In patients with breast cancer, there were significantly more patients presenting at early stage in 2003 compared to 1988, but no difference in the percentage of patients presenting with early stage disease between rural and urban dwellers. There were no differences in incidence in early stage cancer incidence between these groups for melanoma patients, as well. In colorectal cancer in 1988, significantly more patients presented with early stage disease in the urban areas (42% vs 34%, p < 0.02). However, over time the rural patients were diagnosed with early stage disease with the same frequency in 2003 as 1988. CONCLUSION: This analysis demonstrates that people in rural and urban areas have their breast, melanoma or colorectal cancers diagnosed at similar stages. Health care administrators may take this information into account in future strategic planning

Extracting scientific articles from a large digital archive: BioStor and the Biodiversity Heritage Library

Background: The Biodiversity Heritage Library (BHL) is a large digital archive of legacy biological literature, comprising over 31 million pages scanned from books, monographs, and journals. During the digitisation process basic metadata about the scanned items is recorded, but not article-level metadata. Given that the article is the standard unit of citation, this makes it difficult to locate cited literature in BHL. Adding the ability to easily find articles in BHL would greatly enhance the value of the archive. Description: A service was developed to locate articles in BHL based on matching article metadata to BHL metadata using approximate string matching, regular expressions, and string alignment. This article locating service is exposed as a standard OpenURL resolver on the BioStor web site http://biostor.org/openurl/. This resolver can be used on the web, or called by bibliographic tools that support OpenURL. Conclusions: BioStor provides tools for extracting, annotating, and visualising articles from the Biodiversity Heritage Library. BioStor is available from http://biostor.org

Occupational Radiation Protection in Interventional Radiology: A Joint Guideline of the Cardiovascular and Interventional Radiology Society of Europe and the Society of Interventional Radiology

No Abstract

Use of traditional medicines in the management of HIV/AIDS opportunistic infections in Tanzania: a case in the Bukoba rural district

Kisangau DP, Lyaruu HVM, Hosea KM, Joseph CC. Use of traditional medicines in the management of HIV/AIDS opportunistic infections in Tanzania: a case in the Bukoba rural district. Journal of Ethnobiology and Ethnomedicine. 2007;3(1): 29.Background: Ethnobotanical surveys were carried out to document herbal remedies used in the management of HIV/AIDS opportunistic infections in Bukoba Rural district, Tanzania. The district is currently an epicenter of HIV/AIDS and although over 90% of the population in the district relies on traditional medicines to manage the disease, this knowledge is impressionistic and not well documented. The HIV/AIDS opportunistic conditions considered during the study were Tuberculosis (TB), Herpes zoster (Shingles), Herpes simplex (Genital herpes), Oral candidiasis and Cryptococcal meningitis. Other symptomatic but undefined conditions considered were skin rashes and chronic diarrhea. Methods: An open-ended semi-structured questionnaire was used in collecting field information. Descriptive statistics were used to analyze the ethnobotanical data collected. Factor of informant consensus (Fic) was used to analyze the ethnobotanical importance of the plants. Results: In the present study, 75 plant species belonging to 66 genera and 41 families were found to be used to treat one or more HIV/AIDS related infections in the district. The study revealed that TB and oral candidiasis were the most common manifestations of HIV/AIDS opportunistic infections affecting most of the population in the area. It unveils the first detailed account of ethnomedical documentation of plants focusing the management of HIV/AIDS related infections in the district. Conclusion: It is concluded that the ethnopharmacological information reported forms a basis for further research to identify and isolate bioactive constituents that can be developed to drugs for the management of the HIV/AIDS opportunistic infections

Health risk assessment of instant noodles commonly consumed in Port Harcourt, Nigeria

The current study investigated the levels of some heavy metals [Lead (Pb), Arsenic (As), Nickel (Ni), Mercury (Hg), Copper (Cu), Cadmium (Cd), Aluminium (Al) and Chromium (Cr)] and Polycyclic Aromatic Hydrocarbons (PAHs) in six brands of instant noodles (CFN, GFC, NGP, GAA, CUN and FCS) commonly consumed in Port Harcourt, Nigeria. Risks of consumption of contaminated noodles were also assessed. Heavy metals content and PAHs were determined using Flame Atomic Absorption Spectrophotometer (AAS) and Gas Chromatography (GC), respectively. Concentration of heavy metals as Pb, Ni, Cu, Al and Cr were detected while As, Hg and Cd were not detected in noodles. High average concentration (mean ± SD mg/kg) of Pb were observed in brands CFN (3.163 ± 0.21) and GFC (1.022 ± 0.08) which were significantly higher (P≤0.05) than in NGP (0.043 ± 0.15) and GAA (0.276 ± 0.18), although all were above WHO permissible limits (0.025 mg/kg). Target Hazard Quotient and Hazard Index for Pb were >1 in brands CFN and GFC indicating unacceptable risk. Results of PAHs showed brands had total PAHs (mg/kg) in the order: CFN >CUN >GAA >NGP >FCS > GFC. Although Carcinogenic Risks associated with these noodles are within permissible range, consumption of CFN and GFC could pose greater health risk to consumers. Long term consumption of brands CUN, CFN and GAA may have higher probability of carcinogenesis among consumers. We therefore recommend more diligent regulatory policies and monitoring by relevant Government agencies (WHO, NAFDAC, CPC and SON) to ensure wholesome noodles get to consumers