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.

Health attacks and protection strategies during Gaza's Great March of Return: a mixed methods study using data from WHO's Surveillance System for Attacks on Healthcare.

BACKGROUND: WHO defines an attack on health care as "any act of verbal or physical violence or obstruction or threat of violence that interferes with the availability, access and delivery of curative and/or preventive health services during emergencies." Gaza's Great March of Return (GMR) began on Mar 30, 2018, with 322 Palestinians killed and 33 141 injured by December, 2019, and first-response health-care teams exposed to high levels of violence. The aims of this study were threefold: to explore the vulnerabilities of health workers to attacks during the GMR; to understand the effectiveness and comprehensiveness of systems for monitoring health attacks; and to identify potential strategies and interventions to improve protection. METHODS: WHO's Surveillance System for Attacks on Healthcare (SSA) verifies and records health attacks. We analysed SSA data for the Gaza Strip from Mar 30, 2018, to Dec 31, 2019, examining the number and type of attacks, the mechanisms of injury, and the distribution of attacks by gender, time, and location. We analysed the correlation of health worker injuries and deaths with total injuries and deaths of Palestinians during the GMR. We held interviews and focus groups with individuals working for organizations defined as partners contributing to the SSA in the Gaza Strip, to understand data comprehensiveness, the nature and impact of violence, and protection gaps and strategies. FINDINGS: During the study period, there were 567 confirmed incidents, in which three health workers were killed, 845 health workers were injured, and 129 ambulances and vehicles and 7 health facilities were damaged, including one hospital and three medical field stations. Of the total health personnel killed and injured, 166 of 848 (20%) were in the Gaza governorate, 274 (32%) were in the Khan Yunis governorate, 119 (14%) were in the middle governorate, 192 (22%) were in North governorate, and 96 (11%) were in the Rafah governorate. Of 845 injuries, 743 (88%) were in men, 45 (5%) were live ammunition injuries, 62 (7%) were rubber bullet injuries, 151 (18%) were gas canister injuries, 41 (5%) were shrapnel injuries, and 533 (64%) were gas inhalation injuries. Injuries and deaths among health workers correlated moderately (R2=0·54) with and accounted for 2% of the total. Qualitative findings highlighted the incidental and structural nature of violence, normalisation and under-reporting of attacks, the need for improved coordination of protection for health care, and gaps in the availability of protective equipment. INTERPRETATION: Health-care workers function at great personal risk. The correlation of attacks against health care with total injuries and deaths points to the need for alignment of efforts to protect health care with strategies to safeguard civilian populations, including protection of populations living under occupation and those engaged in civil demonstrations. Health-care workers identified the need for systemic measures to improve protection through training, monitoring, and coordination, and through linking of monitoring and documentation of health attacks with stronger accountability measures for prevention. FUNDING: In 2017 and 2018, WHO's Right to Health Advocacy programme received funding from the Swiss Development Cooperation and the oPt Humanitarian Fund.

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.

Registration of antimicrobials, Kenya, Uganda and United Republic of Tanzania, 2018.

OBJECTIVE: To determine the proportion of essential and non-essential antimicrobial medicines that are registered on the drug registers in Kenya, Uganda and United Republic of Tanzania. METHODS: We categorized all antimicrobials on the national drug registers and essential medicines lists of the three countries using the British National Formulary. We also categorized all antibiotics according to the World Health Organization access, watch and reserve (AWaRe) classification. We calculated the proportions of essential and non-essential antimicrobials that were registered by antimicrobial class and AWaRe classification. FINDINGS: In 2018, Kenya had 2105 registered antimicrobials, Uganda had 1563 and the United Republic of Tanzania had 1327. Of these medicines, 1353 (64.3%) were non-essential in Kenya, 798 (51.1%) in Uganda and 706 (53.2%) in the United Republic of Tanzania. Kenya had 160 antimicrobials on its national essential medicines lists, Uganda had 187 and the United Republic of Tanzania had 182; of these, 33 (20.7%), 50 (26.7%) and 52 (28.6%) were not registered, respectively. High proportions of antimycobacterial and antiparasitic medicines were not registered. Of essential access antibiotics, 14.3% (4/28) were not registered in Kenya, 8.6% (3/35) in Uganda and 20.5% (8/39) in the United Republic of Tanzania, nor were 25.0% (3/12) of watch antibiotics in Kenya, 14.3% (2/14) in Uganda and 19.1% (4/21) in the United Republic of Tanzania. CONCLUSION: Suboptimal registration of essential antimicrobials and over-registration of non-essential antimicrobials may encourage inappropriate use, especially since non-essential antimicrobials do not appear on national treatment guidelines. Countries should prioritize registration of the antimicrobial medicines on their essential medicines lists.

Threats to global antimicrobial resistance control: Centrally approved and unapproved antibiotic formulations sold in India.

AIMS: Rising antimicrobial resistance (AMR) is a global health crisis. India has among the highest resistance rates and antibiotic consumption internationally. Extensive use of fixed-dose combination (FDC) antibiotics and of unapproved formulations are claimed contributory factors but there has been no systematic examination of formulations or volumes sold. The aim of the present study was to investigate the regulatory approval status and sales volumes of systemic antibiotics marketed in India. METHODS: This was an ecological study using regulatory records in India, the UK and the US to determine the approval status in each country of systemic antibiotic FDCs and single-drug formulations (SDFs) sold in India. Pharmatrac® sales data were used to determine the formulations and volumes sold (2007-2012), branded-product numbers and manufacturers. RESULTS: Of 118 systemic antibiotic FDC formulations sold in India, 43 (36%) were approved but 75 (64%) had no record of regulatory approval; four (3%) formulations were approved in the UK and/or US. Almost half of formulations (58/118; 49%) comprised dual antimicrobials, most unapproved in India (43/58; 74%), and many were pharmacologically problematic. In contrast, 80/86 (93%) SDFs were approved in India and over two-thirds in the UK and/or US. Total antibiotic sales increased by 26%, from 2056 million units (2007-08) to 2583 million units (2011-12). FDC sales rose by 38% vs. 20% for SDFs. By 2011-12, FDCs comprised one-third of sales (872 million units). Over one-third of FDCs sold (300.26 million units; 34.5%) were of unapproved formulations. Multinational companies manufactured unapproved formulations and accounted for 19% of all FDC and SDF sales annually. CONCLUSIONS: Sales in India of antibiotic FDCs, including unapproved formulations, are rising. In the context of increasing AMR rates nationally and globally, unapproved antibiotic FDCs undermine India's national AMR strategy and should be banned from sale.

Evidence in support of the call to ban the tackle and harmful contact in school rugby: a response to World Rugby.

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.

Observational Evidence of For-Profit Delivery and Inferior Nursing Home Care: When Is There Enough Evidence for Policy Change?

Margaret McGregor and colleagues consider Bradford Hill's framework for examining causation in observational research for the association between nursing home care quality and for-profit ownership.

Prescribing indicators at primary health care centers within the WHO African region: a systematic analysis (1995-2015).

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.

Use of Fixed Dose Combination (FDC) Drugs in India: Central Regulatory Approval and Sales of FDCs Containing Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Metformin, or Psychotropic Drugs.

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.

Aid conditionalities, international Good Manufacturing Practice standards and local production rights: a case study of local production in Nepal.

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.

Concussion in youth rugby union and rugby league: a systematic review.

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.

Systematic review of rugby injuries in children and adolescents under 21†years.

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.

Assessing equity in the geographical distribution of community pharmacies in South Africa in preparation for a national health insurance scheme.

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.

Loss of population data sources when health systems are not responsible for geographically defined populations: implications of the Health and Social Care Act of 2012 in England.

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.

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.

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.

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.