Global Burden Disease Estimates for Major Depressive Disorders (MDD): A review of diagnostic instruments used in studies of prevalence.

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.

Private sector expansion and the widening NHS treatment gap between rich and poor in England: Admissions for NHS-funded elective primary hip and knee replacements between 1997/98 and 2018/19.

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.

Audit of essential medicine listing and registration status of medicines on standard treatment guidelines in Kenya, Tanzania and Uganda: Case study of malaria, tuberculosis, hypertension and type 2 diabetes mellitus.

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.

A critical appraisal of the quality of data submitted by sub-Saharan African cancer registries to GLOBOCAN 2020.

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.

Regulatory enforcement of the marketing of fixed-dose combinations in India: a case study of systemic antibiotics.

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.

Bridging the gap? Local production of medicines on the national essential medicine lists of Kenya, Tanzania and Uganda.

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.

Systemic antibiotic sales and WHO recommendations, India.

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.

Dismantling the National Health Service in England.

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.

Waiting Times for Cataract Surgery in Scotland since 2002 and the Effect of Austerity: An Interrupted Time Series Analysis.

PURPOSE: In Scotland, in 2002, the National Waiting Times Unit was launched to reduce NHS waiting times. This was accompanied by a series of waiting time targets across the NHS in Scotland. The purpose of this study is to analyse changes in equality of access to treatment by socioeconomic deprivation associated with this initiative. METHODS: Trends in annual cataract rates were calculated using secondary care admissions' Scottish Morbidity Record (SMR01) data on NHS funded elective cataract procedures for patients treated in Scotland from 01 April 1997 to 31 March 2019. An interrupted time series model was used to analyse socioeconomic differences in waiting times by deprivation quintile over three time periods; pre and post waiting time initiative, and post austerity. RESULTS: Cataract Surgical Rates more than doubled from 3,723 per million population in 1997/1998 to 7,896 per million population in 2018/2019. Mean waiting time fell from 129.5 days in 1997/1998 to 87.7 days in 2018/2019. Inequality in mean waiting time between most and least deprived cataract patients increased by 1.34 days per quarter between 01 April 1997 and 30 June 2002 and following the waiting time initiative fell by 0.41 days per quarter through to 31 March 2010; and then decreased by 0.002 days per quarter between 01 April 2010 and 31 March 2019. CONCLUSION: The waiting time initiative had a major impact on reducing inequality in waiting times between socioeconomic groups. The onset of austerity in 2010 was associated with a very small and insignificant increase in inequality.

Socioeconomic inequality, waiting time initiatives and austerity in Scotland: an interrupted time series analysis of elective hip and knee replacements and arthroscopies.

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.

The Global Response to the COVID-19 Pandemic.

Global approaches towards pandemic control range from strict lockdowns to minimal restrictions. We asked experts worldwide about the lessons learned from their countries' response. Their voices converge on the importance of scientifically guided interventions to limit the spread of SARS-CoV-2 and its impact on human health.