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1.
Artículo en Inglés | MEDLINE | ID: mdl-38951416

RESUMEN

Global Burden of Disease (GBD) estimates have significant policy implications nationally and internationally. Disease burden metrics, particularly for depression, have played a critical role in raising governmental awareness of mental health and in calculating the economic cost of depression. Recently, the World Health Organization ranked depression as the single largest contributor to global disability. The main aim of this paper was to assess the basis upon which GBD prevalence estimates for major depressive disorder (MDD) were made. We identify the instruments used in the 2019 GBD estimates and provide a descriptive assessment of the five most frequently used instruments. The majority of country studies, 356/566 (62.9%), used general mental health screeners or structured/semi-structured interview guides, 98/566 (17.3%) of the studies used dedicated depression screeners, and 112 (19.8%) used other tools for assessing depression. Thus, most of the studies used instruments that were not designed to make a diagnosis of depression or assess depression severity. Our results are congruent with and extend previous research that has identified critical flaws in the data underpinning the GBD estimates for MDD. Despite the widespread promotion of these prevalence estimates, caution is needed before using them to inform public policy and mental health interventions. This is particularly important in lower-income countries where resources are scarce.

2.
Bull World Health Organ ; 100(10): 610-619, 2022 Oct 01.
Artículo en Inglés | MEDLINE | ID: mdl-36188020

RESUMEN

Objective: To analyse sales of fixed-dose combination and single antibiotics in India in relation to World Health Organization (WHO) recommendations and national regulatory efforts to control antibiotic sales. Methods: We extracted data on sales volumes of systemic antibiotics in India from a market research company sales database. We compared the market share of antibiotic sales in 2020 by WHO AWaRe (Access, Watch and Reserve) category and for those under additional national regulatory controls. We also analysed sales of fixed-dose combinations that were: formally approved for marketing or had a no-objection certificate; on the national essential medicines list; and on the WHO list of not-recommended antibiotics. Findings: There were 78 single and 112 fixed-dose combination antibiotics marketed in India, accounting for 7.6 and 4.5 billion standard units of total sales, respectively. Access, Watch and Reserve antibiotics comprised 5.8, 5.6 and 0.1 billion standard units of total market sales, respectively. All additionally controlled antibiotics were Watch and Reserve antibiotics (23.6%; 2.9 billion standard units of total sales). Fixed-dose combinations on the WHO not-recommended list were marketed in 229 formulations, with 114 formulations (49.8%) having no record of formal approval or no-objection certificate. While there were no not-recommended fixed-dose combinations on the national list of essential medicines, 13 of the top-20 selling antibiotic fixed-dose combinations were WHO not-recommended. Conclusion: The sale of Watch group drugs, and antibiotics banned or not approved, needs active investigation and enforcement in India. The evidence base underpinning formal approvals and no-objection certificates for not-recommended fixed-dose combinations should be audited.


Asunto(s)
Antibacterianos , Medicamentos Esenciales , Antibacterianos/uso terapéutico , Comercio , Humanos , India , Organización Mundial de la Salud
4.
Br J Sports Med ; 51(15): 1113-1117, 2017 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-28701366

RESUMEN

In a paper published in BJSM (June 2016), World Rugby employees Ross Tucker and Martin Raftery and a third coauthor Evert Verhagen took issue with the recent call to ban tackling in school rugby in the UK and Ireland. That call (to ban tackling) was supported by a systematic review published in BJSM Tucker et al claim that: (1) the mechanisms and risk factors for injury along with the incidence and severity of injury in youth rugby union have not been thoroughly identified or understood; (2) rugby players are at no greater risk of injury than other sports people, (3) this is particularly the case for children under 15 years and (4) removing the opportunity to learn the tackle from school pupils might increase rates of injuries. They conclude that a ban 'may be unnecessary and may also lead to unintended consequences such as an increase in the risk of injury later in participation.' Here we aim to rebut the case by Tucker et al We share new research that extends the findings of our original systematic review and meta-analysis. A cautionary approach requires the removal of the tackle from school rugby as the quickest and most effective method of reducing high injury rates in youth rugby, a public health priority.


Asunto(s)
Traumatismos en Atletas/prevención & control , Fútbol Americano/lesiones , Adolescente , Traumatismos en Atletas/etiología , Conmoción Encefálica/etiología , Conmoción Encefálica/prevención & control , Niño , Humanos , Irlanda , Metaanálisis como Asunto , Medición de Riesgo , Factores de Riesgo , Reino Unido
5.
BMC Public Health ; 16: 724, 2016 08 22.
Artículo en Inglés | MEDLINE | ID: mdl-27545670

RESUMEN

BACKGROUND: Rational medicine use is essential to optimize quality of healthcare delivery and resource utilization. We aim to conduct a systematic review of changes in prescribing patterns in the WHO African region and comparison with WHO indicators in two time periods 1995-2005 and 2006-2015. METHODS: Systematic searches were conducted in PubMed, Scopus, Web of science, Africa-Wide Nipad, Africa Journals Online (AJOL), Google scholar and International Network for Rational Use of Drugs (INRUD) Bibliography databases to identify primary studies reporting prescribing indicators at primary healthcare centres (PHCs) in Africa. This was supplemented by a manual search of retrieved references. We assessed the quality of studies using a 14-point scoring system modified from the Downs and Black checklist with inclusions of recommendations in the WHO guidelines. RESULTS: Forty-three studies conducted in 11 African countries were included in the overall analysis. These studies presented prescribing indicators based on a total 141,323 patient encounters across 572 primary care facilities. The results of prescribing indicators were determined as follows; average number of medicines prescribed per patient encounter = 3.1 (IQR 2.3-4.8), percentage of medicines prescribed by generic name =68.0 % (IQR 55.4-80.3), Percentage of encounters with antibiotic prescribed =46.8 % (IQR 33.7-62.8), percentage of encounters with injection prescribed =25.0 % (IQR 18.7-39.5) and the percentage of medicines prescribed from essential medicines list =88.0 % (IQR 76.3-94.1). Prescribing indicators were generally worse in private compared with public facilities. Analysis of prescribing across two time points 1995-2005 and 2006-2015 showed no consistent trends. CONCLUSIONS: Prescribing indicators for the African region deviate significantly from the WHO reference targets. Increased collaborative efforts are urgently needed to improve medicine prescribing practices in Africa with the aim of enhancing the optimal utilization of scarce resources and averting negative health consequences.


Asunto(s)
Atención a la Salud/normas , Prescripciones de Medicamentos/normas , Adhesión a Directriz , Pautas de la Práctica en Medicina/tendencias , Atención Primaria de Salud/normas , África , Antibacterianos/uso terapéutico , Medicamentos Esenciales , Recursos en Salud/estadística & datos numéricos , Humanos , Inyecciones , Estudios Retrospectivos , Organización Mundial de la Salud
6.
PLoS Med ; 12(5): e1001826; discussion e1001826, 2015 May.
Artículo en Inglés | MEDLINE | ID: mdl-25965416

RESUMEN

BACKGROUND: In 2012, an Indian parliamentary committee reported that manufacturing licenses for large numbers of fixed dose combination (FDC) drugs had been issued by state authorities without prior approval of the Central Drugs Standard Control Organization (CDSCO) in violation of rules, and considered that some ambiguity until 1 May 2002 about states' powers might have contributed. To our knowledge, no systematic enquiry has been undertaken to determine if evidence existed to support these findings. We investigated CDSCO approvals for and availability of oral FDC drugs in four therapeutic areas: analgesia (non-steroidal anti-inflammatory drugs [NSAIDs]), diabetes (metformin), depression/anxiety (anti-depressants/benzodiazepines), and psychosis (anti-psychotics). METHODS AND FINDINGS: This was an ecologic study with a time-trend analysis of FDC sales volumes (2007-2012) and a cross-sectional examination of 2011-2012 data to establish the numbers of formulations on the market with and without a record of CDSCO approval ("approved" and "unapproved"), their branded products, and sales volumes. Data from the CDSCO on approved FDC formulations were compared with sales data from PharmaTrac, a database of national drug sales. We determined the proportions of FDC sales volumes (2011-2012) arising from centrally approved and unapproved formulations and from formulations including drugs banned/restricted internationally. We also determined the proportions of centrally approved and unapproved formulations marketed before and after 1 May 2002, when amendments were made to the drug rules. FDC approvals in India, the United Kingdom (UK), and United States of America (US) were compared. For NSAID FDCs, 124 formulations were marketed, of which 34 (27%) were centrally approved and 90 (73%) were unapproved; metformin: 25 formulations, 20 (80%) approved, five (20%) unapproved; anti-depressants/benzodiazepines: 16 formulations, three (19%) approved, 13 (81%) unapproved; anti-psychotics: ten formulations, three (30%) approved, seven (70%) unapproved. After 1 May 2002, the proportions of approved FDC formulations increased for NSAIDs (26%/28%) and anti-psychotics (0%/38%) and decreased for metformin (100%/75%) and anti-depressants/benzodiazepines (20%/18%), and the overall proportion approved remained similar before and after that date. FDC formulations gave rise to multiple branded products, ranging from 211 anti-psychotic FDC products from ten formulations to 2,739 NSAID FDC products from 124 formulations. The proportions of FDC sales volumes arising from unapproved formulations were as follows: anti-depressants/benzodiazepines, 69%; anti-psychotics, 43%; NSAIDs, 28%; and metformin, 0.4%. Formulations including drugs banned/restricted internationally comprised over 12% of NSAID FDC sales and 53% of anti-psychotic FDC sales. Across the four therapeutic areas, 14 FDC formulations were approved in the UK and 22 in the US. CONCLUSIONS: There was evidence supporting concerns about FDCs. Metformin excepted, substantial numbers of centrally unapproved formulations for NSAID, anti-depressant/benzodiazepine, and anti-psychotic FDCs were marketed; sales volumes were high. The legal need for central approval of new drugs before manufacture has been in place continuously since 1961, including for FDCs meeting the applicable legal test. Proportions of centrally unapproved formulations after 1 May 2002 did not decrease overall, and no ambiguity was found about states' licensing powers. Unapproved formulations should be banned immediately, prioritising those withdrawn/banned internationally and undertaking a review of benefits and risks for patients in ceasing or switching to other medicines. Drug laws need to be amended to ensure the safety and effectiveness of medicines marketed in India.


Asunto(s)
Antiinflamatorios no Esteroideos/administración & dosificación , Metformina/administración & dosificación , Psicotrópicos/administración & dosificación , Combinación de Medicamentos , Humanos , India , Legislación de Medicamentos
7.
Global Health ; 11: 25, 2015 Jun 14.
Artículo en Inglés | MEDLINE | ID: mdl-26072308

RESUMEN

BACKGROUND: Local pharmaceutical production has been endorsed by the WHO as a means of addressing health priorities of developing countries. However, local producers of essential medicines must comply with international pharmaceutical standards in order to be eligible to compete in donor tenders. These standards determine production rights for on-patent and off-patent medicines, and guide international procurement of medicines. We reviewed the literature on the impact of Good Manufacturing Practice (GMP) on local production; a gap analysis from the literature review indicated a need for further research. Over sixty interviews were conducted with people involved in the Nepali pharmaceutical production and distribution chain from 2006 to 2009 on the GMP areas of relevance: regulatory capacity, staffing, funding and training, resourcing of GMP, inspectors' interpretation of the rules and compliance. RESULTS: Although Nepal producers have increased their overall share of the domestic market, only the public manufacturer, Royal Drugs, focuses on medicines for public health programmes; private producers engage mainly in brand competition for private markets, not essential medicines. Nepali regulators and producers state that implementation of GMP standards is hindered by low regulatory capacity, insufficient training of staff in the industry, financial constraints and lack of investment for upgrading capital. The transition period to mandatory compliance with WHO GMP rules is lengthy. Less than half of private producers had WHO GMP in 2013. Producers are not directly affected by international harmonisation of standards as they do not export medicines and the Nepali regulator does not enforce the WHO standards strictly. Without an international GMP certificate they cannot tender for donor dependent health programmes. CONCLUSIONS: In Nepal, local private manufacturers focus mainly on brand competition for private consumption not essential medicines, the government preferentially procures essential medicines from the only public producer while donor funded programmes rely on international manufacturers compliant with international GMP standards. We also found evidence of private hospitals bypassing national medicines approvals process. Policies in support of local pharmaceutical production in developing countries as a source of essential medicines need to examine carefully how GMP regulations impact on regulators, local industry and production of essential medicines in practice.


Asunto(s)
Comercio , Industria Farmacéutica/normas , Humanos , Entrevistas como Asunto , Nepal , Estudios de Casos Organizacionales , Medicamentos bajo Prescripción/provisión & distribución , Investigación Cualitativa
8.
Br J Sports Med ; 49(8): 506-10, 2015 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-25586912

RESUMEN

BACKGROUND: Children and adolescents who play rugby are at increased risk of concussion and its effects. Competitive rugby union and rugby league feature as major sports in the school sport curriculum in the UK. There is a need for a thorough understanding of the epidemiology of concussion in youth rugby, the mechanisms involved in injuries and predisposing risk factors. DATA SOURCES: The publication databases Pubmed, Embase and SportDISCUS were searched in April 2014 for primary research studies of child and adolescent rugby union and rugby league (under 20 years) in English language with data on concussion injuries. The review was conducted within a larger all injury systematic review on rugby union and rugby league where key words used in the search included rugby, injury and concussion with child, adolescent, paediatric and youth. RESULTS: There were 25 studies retrieved with data on child or adolescent rugby and concussion, 20 were on rugby union, three on rugby league and in two the code of rugby was unspecified. There was significant heterogeneity in the definitions of injuries and of concussion. The incidence of child and adolescent match concussion ranged from 0.2 to 6.9 concussions per 1000 player-hours for rugby union and was 4.6 and 14.7 concussions per 1000 player-hours for rugby league, equivalent to a probability of between 0.3% and 11.4% for rugby union and of 7.7% and 22.7% for rugby league. CONCLUSIONS: There is a significant risk of concussion in children and adolescents playing rugby union and rugby league evident from the studies included in this systematic review. There is a need for reliable data through routine monitoring and reporting in schools and clubs and in hospital emergency departments in order to inform prevention. Concussion protocols should be implemented and tested.


Asunto(s)
Conmoción Encefálica/epidemiología , Fútbol Americano/lesiones , Adolescente , Traumatismos en Atletas/epidemiología , Traumatismos en Atletas/etiología , Traumatismos en Atletas/prevención & control , Conmoción Encefálica/etiología , Conmoción Encefálica/prevención & control , Niño , Femenino , Humanos , Incidencia , Masculino , Factores de Riesgo , Distribución por Sexo
9.
Br J Sports Med ; 49(8): 511-9, 2015 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-25564004

RESUMEN

A systematic review of rugby union and league injuries among players under the age of 21 years was carried out to calculate probabilities of match injury for a player over a season and a pooled estimate of match injury incidence where studies were sufficiently similar. The probability of a player being injured over a season ranged from 6% to 90% for rugby union and 68% to 96% for rugby league. The pooled injury incidence estimate for rugby union was 26.7/1000 player-hours for injuries irrespective of need for medical attention or time-loss and 10.3/1000 player-hours for injuries requiring at least 7 days absence from games; equivalent to a 28.4% and 12.1% risk of being injured over a season. Study heterogeneity contributed to a wide variation in injury incidence. Public injury surveillance and prevention systems have been successful in reducing injury rates in other countries. No such system exists in the UK.


Asunto(s)
Fútbol Americano/lesiones , Absentismo , Adolescente , Traumatismos en Atletas/epidemiología , Conmoción Encefálica/epidemiología , Niño , Contusiones/epidemiología , Traumatismos Craneocerebrales/epidemiología , Extremidades/lesiones , Femenino , Hematoma/epidemiología , Humanos , Incidencia , Luxaciones Articulares/epidemiología , Laceraciones/epidemiología , Masculino , Traumatismos del Cuello/epidemiología , Medición de Riesgo , Esguinces y Distensiones/epidemiología , Torso/lesiones , Adulto Joven
10.
Bull World Health Organ ; 92(7): 482-9, 2014 Jul 01.
Artículo en Inglés | MEDLINE | ID: mdl-25110373

RESUMEN

OBJECTIVE: To investigate equity in the geographical distribution of community pharmacies in South Africa and assess whether regulatory reforms have furthered such equity. METHODS: Data on community pharmacies from the national department of health and the South African pharmacy council were used to analyse the change in community pharmacy ownership and density (number per 10,000 residents) between 1994 and 2012 in all nine provinces and 15 selected districts. In addition, the density of public clinics, alone and with community pharmacies, was calculated and compared with a national benchmark of one clinic per 10,000 residents. Interviews were conducted with nine national experts from the pharmacy sector. FINDINGS: Community pharmacies increased in number by 13% between 1994 and 2012--less than the 25% population growth. In 2012, community pharmacy density was higher in urban provinces and was eight times higher in the least deprived districts than in the most deprived ones. Maldistribution persisted despite the growth of corporate community pharmacies. In 2012, only two provinces met the 1 per 10,000 benchmark, although all provinces achieved it when community pharmacies and clinics were combined. Experts expressed concerns that a lack of rural incentives, inappropriate licensing criteria and a shortage of pharmacy workers could undermine access to pharmaceutical services, especially in rural areas. CONCLUSION: To reduce inequity in the distribution of pharmaceutical services, new policies and legislation are needed to increase the staffing and presence of pharmacies.


Asunto(s)
Programas Nacionales de Salud , Farmacias/provisión & distribución , Accesibilidad a los Servicios de Salud , Investigación sobre Servicios de Salud , Disparidades en Atención de Salud , Humanos , Sudáfrica
12.
Evid Based Med ; 19(1): 4-5, 2014 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-23645887

RESUMEN

Biomedical health services and health systems research require timely, complete, accurate and accessible data relating to geographical populations in order to facilitate needs assessment and planning of medical care, new medicines and technology. The international trend towards competition and privatisation has largely proceeded as if data generation were immune to market fragmentation and loss of universal coverage. By examining recent reforms to the English National Health Service, the authors show that this is not the case. Routine and population data are products of administrative systems and the nature, completeness and quality of data available to clinical and public health researchers are substantially impaired by market reforms.


Asunto(s)
Atención a la Salud/legislación & jurisprudencia , Medicina Estatal/legislación & jurisprudencia , Recolección de Datos , Bases de Datos Factuales , Atención a la Salud/organización & administración , Atención a la Salud/estadística & datos numéricos , Reforma de la Atención de Salud/legislación & jurisprudencia , Reforma de la Atención de Salud/organización & administración , Humanos , Medicina Estatal/organización & administración , Medicina Estatal/estadística & datos numéricos , Reino Unido/epidemiología
13.
Health Policy ; 146: 105118, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38941686

RESUMEN

Parliament has imposed duties on the government and NHS in England aimed at reducing health inequalities. AIM: to understand the effect on inequalities of government policies, which require the NHS in England to outsource elective surgery to the private sector. We analysed the numbers of admissions for hip and knee replacement surgery from the least and most deprived population quintiles in three time periods: before the introduction of the policies (1997/98-2002/03); following the implementation of the independent sector treatment centre programme (2003/04-2006/07); and after the extension of 'choice at referral' (2007/08-2018/19). RESULTS: despite admission rates doubling and trebling for hip and knee replacements, respectively, between 1997/98 and 2018/19, inequality grew to the detriment of the most deprived. Inequality grew at the fastest rate during period 3; admission rates to the NHS fell while admissions to the private sector continued to rise. By 2018/19 almost a third of NHS funded procedures were provided privately. In 1997/98, for every 10 patients admitted for hip and knee surgery from the most deprived quintile, 13 and 9, respectively were admitted from the least deprived, by 2018/19 the gap had widened to 19 and 15, respectively. Socio-economic inequalities for hip and knee replacement have widened as outsourcing of NHS treatment to the private sector has increased. The NHS must rebuild in-house capacity and provision instead of outsourcing care.


Asunto(s)
Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Procedimientos Quirúrgicos Electivos , Sector Privado , Medicina Estatal , Humanos , Artroplastia de Reemplazo de Rodilla/estadística & datos numéricos , Artroplastia de Reemplazo de Cadera/estadística & datos numéricos , Inglaterra , Procedimientos Quirúrgicos Electivos/estadística & datos numéricos , Disparidades en Atención de Salud , Femenino , Masculino
14.
JRSM Open ; 15(1): 20542704231217888, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-38223747

RESUMEN

Objectives: (a) To critically appraise the quality of data submitted by sub-Saharan African (SSA) cancer registries to GLOBOCAN 2020 and (b) compare the quality of data of the registries common to GLOBOCAN 2008 and 2020. Design: Critical appraisal of cancer registry data quality using the Parkin and Bray framework. Setting and Participants: GLOBOCAN 2020 cancer registry estimates for 46 countries in SSA. Forty-three registries in 31 (SSA) countries were identified from the GLOBCAN 2020 supplementary documents, of which data from 28 registries in 23 sub-Saharan African countries were publicly available. Main outcomes measures: Data quality for 15 variables in four domains (comparability, validity, timeliness and completeness) were appraised using the Parkin and Bray framework. Results from the appraisal of GLOBOCAN 2020 sources were compared with previous findings for GLOBOCAN 2008. Results: Compared with GLOBOCAN 2008, GLOBOCAN 2020 country coverage had increased from 21 to 31 countries with 15 countries having no established registries. Out of a total possible score of 15 for data quality, 18 of the 28 publicly available GLOBOCAN 2020 registries fulfilled a score of 5 or more compared with seven registries in GLOBOCAN 2008. Of the 17 registries common to GLOBOCAN 2008 and 2020, nine showed an improvement in data quality. Conclusion: Country coverage and data quality have improved since GLOBOCAN 2008, however, overall data quality and coverage remain poor. GLOBOCAN 2020 estimates should be used with caution when allocating resources.

15.
JRSM Open ; 15(3): 20542704241232814, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38560365

RESUMEN

Objectives: To determine alignment between national and World Health Organization (WHO) treatment recommendations, medicines prioritisation in country's essential medicines list (EML), and medicines availability in National drug register. Design: An audit of medicines for malaria, tuberculosis, hypertension and type 2 diabetes mellitus listed in the national standard treatment guidelines (STGs) of Kenya, Tanzania and Uganda, as of March 2021, against WHO treatment guidelines, and respective country EML and National drug register. Setting: Not applicable. Participants: None. Main outcome measures: Proportion of medicine in country's STGs that align with WHO treatment recommendations, country's EML and country's drug register. Results: Some disease areas had two sets of treatment guidelines - national STGs and disease-specific treatment guidelines (DSGs) developed at different times with different recommended medicines. Both STGs and DSGs included medicines not recommended by the WHO or not listed on the country EML and drug register. Non-WHO-recommended medicines accounted for 17/68 (25%), 10/57 (18%) and 3/30 (10%) of all STG medicines in Kenya, Tanzania and Uganda, respectively. For tuberculosis, the numbers and proportion of STG medicines listed on the respective national EMLs were 2/6 (33%), 15/19 (79%) and 4/5 (80%) in Kenya, Tanzania and Uganda. All tuberculosis medicines included in Kenya's and Uganda's STGs were registered compared with only 12/19 (63%) tuberculosis medicines in Tanzania's STG. Conclusions: Alignment between treatment guidelines, EMLs and drug registers is crucial for effective national pharmaceutical policy. Research is needed to understand the inclusion of medicines on STGs and DSGs which fall outside WHO treatment guidelines; the non-alignment of some STGs and DSGs, and STGs and DSGs including medicines which are not on country EML and drug register.

16.
J Pharm Policy Pract ; 16(1): 18, 2023 Jan 30.
Artículo en Inglés | MEDLINE | ID: mdl-36717871

RESUMEN

BACKGROUND: Essential medicines (EMs) are those that satisfy the basic healthcare needs of the population. However, access to EMs remains a global health challenge. The World Health Organization (WHO) and the East African Community (EAC) manufacturing plan 2017-2027 support local production of EMs as a strategy to improve access to medicines. The aim of this study was to determine for each therapeutic class on the national essential medicine lists (NEMLs) of Kenya, Tanzania and Uganda, the number of EMs produced in each country. METHODS: In 2018, we analysed NEMLs and national drug registers (NDRs) in each country to identify local manufacturers and local products by EM status. For each local manufacturer we determined the number of EM products and individual EMs, and analysed EMs in each therapeutic class by registration status and whether produced locally. RESULTS: There were nine companies manufacturing locally in Kenya, four in Tanzania and six in Uganda. Most local medicine products were non-EM products. Of the 946 locally produced products in Kenya, 310 were EM products; of the 97 locally produced products in Tanzania, 39 were EM products; and of the 181 locally produced products in Uganda, 100 were EM products. Many local EM products were duplicate. Only a small proportion of EMs on each NEML were produced locally: 21% (92/430) in Kenya, 5% (24/510) in Tanzania, and 10% (55/526) in Uganda. Kenya, Tanzania and Uganda had no local EM products in 13/32, 17/28 and 15/32 therapeutic classes, respectively. The proportion of EMs that were registered varied across the countries from 327 (76%) in Kenya, 269 (53%) in Tanzania, and 319 (60%) in Uganda. CONCLUSIONS: This study highlights the importance of auditing NDRs and NEMLs for local production to inform regional and national local manufacturing strategies. EMs should be prioritized for local production and drug registration to ensure that production is aligned with local health needs.

17.
J Pharm Policy Pract ; 16(1): 139, 2023 Nov 10.
Artículo en Inglés | MEDLINE | ID: mdl-37950272

RESUMEN

BACKGROUND: In India, states have licensed the manufacture of large numbers of fixed-dose combination (FDC) drugs without the required prior approval of the central regulator. This paper describes two major regulatory initiatives to address the problem, which began in 2007 and 2013, and examines whether they have been sufficient to remove centrally unapproved systemic antibiotic FDCs from the market. METHODS: Information was extracted from documents published by the central regulator and the ministry of health, including the National List of Essential Medicines (NLEM), and court judgments, and analysed alongside sales volume data for 2008-2020 using PharmaTrac market dataset. RESULTS: The regulatory initiatives permitted 68 formulations to be given de facto approvals ('No Objection Certificates') outside the statutory regime, banned 46 FDCs and restricted one FDC. Market data show that FDCs as a proportion of total antibiotic sales increased from 32.9 in 2008 to 37.3% in 2020. The total number of antibiotic FDC formulations on the market fell from 574 (2008) to 395 (2020). Formulations with a record of prior central approval increased from 86 (2008) to 94 (2020) and their share of the antibiotic FDC sales increased from 32.0 to 55.3%. In 2020, an additional 23 formulations had been permitted de facto approval, accounting for 10.6% of the antibiotic FDC sales. Even in 2020, most marketed formulations (70.4%, 278/395) were unapproved or banned, and comprised a 15.9% share of the antibiotic FDC sales. The share of NLEM-listed antibiotic FDC sales increased from 21.2 (2008) to 26.7% (2020). CONCLUSION: The initiatives had limited impact. Regulatory enforcement has been slow and weak, with many unapproved, and even banned, FDCs remaining on the market.

18.
Br J Sports Med ; 46(8): 611-3, 2012 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-21957194

RESUMEN

BACKGROUND: The communication of injury risk in rugby and other sports is underdeveloped and parents, children and coaches need to be better informed about risk. METHOD: A Poisson distribution was used to transform population based incidence of injury into average probabilities of injury to individual players. RESULTS: The incidence of injury in schoolboy rugby matches range from 7 to 129.8 injuries per 1000 player-hours; these rates translate to average probabilities of injury to a player of between 12% and 90% over a season. CONCLUSION: Incidence of injury and average probabilities of injury over a season should be published together in all future epidemiological studies on school rugby and other sports. More research is required on informing and communicating injury risks to parents, staff and children and how it affects monitoring, decision making and prevention strategies.


Asunto(s)
Comunicación , Fútbol Americano/lesiones , Educación en Salud/métodos , Adolescente , Traumatismos en Atletas/epidemiología , Niño , Fútbol Americano/estadística & datos numéricos , Humanos , Incidencia , Masculino , Distribución de Poisson , Factores de Riesgo , Reino Unido/epidemiología
19.
Int J Health Serv ; 52(4): 470-479, 2022 10.
Artículo en Inglés | MEDLINE | ID: mdl-35876348

RESUMEN

The National Health Service was established in the United Kingdom in 1948 as a universal, comprehensive service free at the point of delivery, which is publicly provided, funded, and accountable. Market incrementalism in England has eroded this system over three decades. The recently enacted Health and Care Act will erode it further. This article first explains briefly how legislation and policy initiatives in 1990, 2003, and 2012 furthered development of the market and private provision of health services, and then describes the main structural changes in the new Act and their implications. England is now moving decisively toward a marketized, two-tier, mixed-funding system with several similarities to the United States.


Asunto(s)
Servicios de Salud , Medicina Estatal , Inglaterra , Humanos , Reino Unido , Estados Unidos
20.
J R Soc Med ; 115(10): 399-407, 2022 10.
Artículo en Inglés | MEDLINE | ID: mdl-35413211

RESUMEN

OBJECTIVES: National Health Service (NHS) waiting times have long been a political priority in Scotland. In 2002, the Scottish government launched a programme of investment and reform to reduce waiting times. The effect on waiting time inequality is unknown as is the impact of subsequent austerity measures. DESIGN: An interrupted time series analysis between the most and least socioeconomically deprived population quintiles since the introduction of waiting time initiative 1 July 2002 and austerity measures 1 April 2010. SETTING: All NHS-funded elective primary hip replacement, primary knee replacement and arthroscopy patient data in Scotland from 1 April 1997 to 31 March 2019. PARTICIPANTS: NHS Scotland funded patients treated in Scotland. MAIN OUTCOME MEASURES: Trends and changes in mean waiting time. RESULTS: There were 135,176, 122,883 and 173,976 NHS funded hip replacement, knee replacement and arthroscopy patients, respectively, in Scotland between 1 April 1997 and 31 March 2019. From 1 July 2002 to 31 March 2010, waiting time inequality between the most and least deprived patients fell and increased thereafter. For hip replacements before 1 July 2002, waiting time inequality increased 1.07 days per quarter; this changed at 1 July 2002 with significant slope change of -2.32 (-3.53, -1.12) days resulting in a decreasing rate of inequality of -1.26 days per quarter. On 1 April 2010 the slope changed significantly by 1.84 (0.90, 2.78) days restoring increasing inequality at 0.58 days per quarter. Knee replacements and arthroscopies had similar results. CONCLUSIONS: The waiting time initiative in Scotland is associated with a reduction in waiting time inequality benefiting the most socioeconomically deprived patients. Austerity measures may be reversing these gains.


Asunto(s)
Artroscopía , Listas de Espera , Humanos , Análisis de Series de Tiempo Interrumpido , Medicina Estatal , Factores Socioeconómicos , Escocia
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