Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison.

Biosimilars are biological medicines highly similar to a previously licensed reference product and their licensing is expected to improve access to biological therapies. This study aims to present an overview of biosimilars approval by thirteen regulatory authorities (RA). The study is a cross-national comparison of regulatory decisions involving biosimilars in Argentina, Australia, Brazil, Chile, Canada, Colombia, Europe, Hungary, Guatemala, Italy, Mexico, Peru and United States. We examined publicly available documents containing information regarding the approval of biosimilars and investigated the publication of public assessment reports for registration applications, guidelines for biosimilars licensing, and products approved. Data extraction was conducted by a network of researchers and regulatory experts. All the RA had issued guidance documents establishing the requirements for the licensing of biosimilars. However, only three RA had published public assessment reports for registration applications. In total, the investigated jurisdictions had from 19 to 78 biosimilars approved, most of them licensed from 2018 to 2020. In spite of the advance in the number of products in recent years, some challenges still persist. Limited access to information regarding the assessment of biosimilars by RA can affect confidence, which may ultimately impact adoption of these products in practice.

Data sources for drug utilization research in Latin American countries-A cross-national study: DASDUR-LATAM study.

PURPOSE: Drug utilization research (DUR) contributes to inform policymaking and to strengthen health systems. The availability of data sources is the first step for conducting DUR. However, documents that systematize these data sources in Latin American (LatAm) countries are not known. We compiled the potential data sources for DUR in the LatAm region. METHODS: A network of DUR experts from nine LatAm countries was assembled and experts conducted: (i) a website search of the government, academic, and private health institutions; (ii) screening of eligible data sources, and (iii) liaising with national experts in pharmacoepidemiology (via an online survey). The data sources were characterized by accessibility, geographic granularity, setting, sector of the data, sources and type of the data. Descriptive analyses were performed. RESULTS: We identified 125 data sources for DUR in nine LatAm countries. Thirty-eight (30%) of them were publicly and conveniently available; 89 (71%) were accessible with limitations, and 18 (14%) were not accessible or lacked clear rules for data access. From the 125 data sources, 76 (61%) were from the public sector only; 46 (37%) were from pharmacy records; 43 (34%) came from ambulatory settings and; 85 (68%) gave access to individual patient-level data. CONCLUSIONS: Although multiple sources for DUR are available in LatAm countries, the accessibility is a major challenge. The procedures for accessing DUR data should be transparent, feasible, affordable, and protocol-driven. This inventory could permit a comparison of drug utilization between countries identifying potential medication-related problems that need further exploration.

Working With Lesbian, Gay, Bisexual, and Transgender Clients: Occupational Therapy Practitioners' Knowledge, Skills, and Attitudes.

IMPORTANCE: A lack of health care provider knowledge and training has been identified as one factor that contributes to health disparities for sexual and gender minority (SGM) populations. OBJECTIVE: To explore occupational therapy practitioners' self-reported knowledge about, clinical preparedness for, and attitudes toward working with lesbian, gay, bisexual, and transgender (LGBT) clients. DESIGN: Online survey of occupational therapy practitioners. PARTICIPANTS AND SETTING: Respondents were recruited by means of snowball sampling through social media groups, state occupational therapy association websites, and emails. Surveys were posted to electronic occupational therapy social media sites. MEASURES: Knowledge, clinical preparedness, and attitudes were measured using the Lesbian, Gay, Bisexual, and Transgender Development of Clinical Skills Scale (LGBT-DOCSS). Information about demographic characteristics, education, and workplace was also collected. RESULTS: Five hundred eighty-nine occupational therapy practitioners responded to the survey. Degree level (master's vs. bachelor's or less), continuing education (minimum 1-2 hr of LGBT-specific training), practice setting (mental health), minority sexual orientation, and having a close friend or family member who identifies as SGM were associated with higher mean scores on the LGBT-DOCSS. Higher religiosity and frequency of religious practice were associated with lower scores on knowledge and attitudinal awareness. CONCLUSIONS AND RELEVANCE: Occupational therapy practitioners often care for clients from backgrounds and cultures that differ from their own. Identifying gaps in education and opportunities for fostering LGBT-positive attitudes can facilitate the development of programs to improve practice with LGBT clients and help measure the effectiveness of such programs. What This Article Adds: This study provides evidence that a basic level of continuing education can improve occupational therapy practitioners' knowledge of and skills for working with LGBT populations and highlights the need to examine and change structural biases.

Costs of insecticide-treated bed net distribution systems in sub-Saharan Africa.

BACKGROUND: Insecticide-treated nets (ITNs) are one of the most cost-effective measures for preventing malaria. The World Health Organization recommends both large-scale mass distribution campaigns and continuous distributions (CD) as part of a multifaceted strategy to achieve and sustain universal access to ITNs. A combination of these strategies has been effective for scaling up ITN access. For policy makers to make informed decisions on how to efficiently implement CD or combined strategies, information on the costs and cost-effectiveness of these delivery systems is necessary, but relatively few published studies of the cost continuous distribution systems exist. METHODS: To address the gap in continuous distribution cost data, four types of delivery systems-CD through antenatal care services (ANC) and the expanded programme on immunization (EPI) (Ghana, Mali, and mainland Tanzania), CD through schools (Ghana and mainland Tanzania), and a combined community/health facility-based distribution (Zanzibar, Tanzania), as well as mass distributions (Mali)-were costed. Data on costs were collected retrospectively from financial and operational records, stakeholder interviews, and resource use surveys. RESULTS: Overall, from a full provider perspective, mass distributions and continuous systems delivered ITNs at overlapping economic costs per net distributed (mass distributions: 4.37-4.61 USD, CD channels: 3.56-9.90 USD), with two of the school-based systems and the mass distributions at the lower end of this range. From the perspective of international donors, the costs of the CD systems were, for the most part, less costly than the mass distributions (mass distributions: 4.34-4.55 USD, Ghana and Tanzania 2017 school-based: 3.30-3.69 USD, health facility-based: 3.90-4.55 USD, combined community/health facility 4.55 USD). The 2015 school-based distribution (7.30 USD) and 2016 health facility-based distribution (6.52 USD) programmes in Tanzania were an exception. Mass distributions were more heavily financed by donors, while CD relied more extensively on domestic resource contributions. CONCLUSIONS: These results suggest that CD strategies can continue to deliver nets at a comparable cost to mass distributions, especially from the perspective of the donor.

Age and gender trends in insecticide-treated net use in sub-Saharan Africa: a multi-country analysis.

BACKGROUND: The degree to which insecticide-treated net (ITN) supply accounts for age and gender disparities in ITN use among household members is unknown. This study explores the role of household ITN supply in the variation in ITN use among household members in sub-Saharan Africa. METHODS: Data was from Malaria Indicator Surveys or Demographic and Health Surveys collected between 2011 and 2016 from 29 countries in sub-Saharan Africa. The main outcome was ITN use the previous night. Other key variables included ITN supply (nets/household members), age and gender of household members. Analytical methods included logistic regressions and meta-regression. RESULTS: Across countries, the median (range) of the percentage of households with enough ITNs was 30.7% (8.5-62.0%). Crude analysis showed a sinusoidal pattern in ITN use across age groups of household members, peaking at 0-4 years and again around 30-40 years and dipping among people between 5-14 and 50+ years. This sinusoidal pattern was more pronounced in households with not enough ITNs compared to those with enough ITNs. ITN use tended to be higher in females than males in households with not enough ITNs while use was comparable among females and males in households with enough ITNs. After adjusting for wealth quintile, residence and region, among households with not enough ITNs in all countries, the odds of ITN use were consistently higher among children under 5 years and non-pregnant women 15-49 years. Meta-regressions showed that across all countries, the mean adjusted odds ratio (aOR) of ITN use among children under 5 years, pregnant and non-pregnant women aged 15-49 years and people 50 years and above was significantly higher than among men aged 15-49 years. Among these household members, the relationship was attenuated when there were enough ITNs in the household (dropping 0.26-0.59 points) after adjusting for geographical zone, household ITN supply, population ITN access, and ITN use:access ratio. There was no significant difference in mean aOR of ITN use among school-aged children compared to men aged 15-49 years, regardless of household ITN supply. CONCLUSIONS: This study demonstrated that having enough ITNs in the household increases level of use and decreases existing disparities between age and gender groups. ITN distribution via mass campaigns and continuous distribution channels should be enhanced as needed to ensure that households have enough ITNs for all members, including men and school-aged children.

Impact of a 15-month multi-channel continuous distribution pilot on ITN ownership and access in Eastern Region, Ghana.

BACKGROUND: Insecticide-treated nets are a key intervention for malaria prevention. While mass distribution can rapidly scale up ITN coverage, multiple channels may be needed to sustain high levels of ITN access and ownership. In Ghana's Eastern Region, a continuous ITN distribution pilot, started in October 2012, 18-24 months after a mass campaign. The pilot distributed ITNs through antenatal care services (ANC), child welfare clinic services (CWC) through the Expanded Programme on Immunization, and to students in two classes of primary schools. METHODS: ITN ownership and access were evaluated through two cross-sectional surveys, conducted at baseline in April 2012, 11-15 months after the mass campaign, and at endline in December 2013, after 1 year of continuous distribution. A representative sample was obtained using a multi-stage cluster sampling design. Household heads were interviewed using a structured questionnaire. RESULTS: Household ownership of at least one ITN was 91.3% (95% CI 88.8-93.9) at baseline and was not statistically significant at endline 18 months later at 88.3% (95% CI 84.9-91.0) (p = 0.10). Ownership of at least 1 ITN per two people significantly decreased from 51.3% (95% CI 47.1-55.4) to 40.2% (95% CI 36.4-44.6) (p < 0.01). Population access to an ITN within the household also significantly decreased from 74.5% (95% CI 71.2-77.7) at baseline to 66.4% (95% CI 62.9-69.9) at endline (p < 0.01). The concentration index score for any CD channel was slightly positive (0.10; 95% CI 0.04-0.15). CONCLUSION: Thirty-one months after the mass campaign, the 15 months of continuous distribution activities had maintained levels of household ownership at least one ITN, but household ownership of one ITN for every two people and population access to ITN had declined. Ownership and access were higher with the CD programme than without. However, the number of ITNs delivered via ANC, CWC and two primary school classes were insufficient to sustain coverage targets. Future programmes should implement continuous distribution strategies fully within 1 year after a campaign or widen eligibility criteria (such as increase the number of classes) during the first year of implementation to make up for programme delays.

Multi-country comparison of delivery strategies for mass campaigns to achieve universal coverage with insecticide-treated nets: what works best?

BACKGROUND: The use of insecticide-treated nets (ITNs) is widely recognized as one of the main interventions to prevent malaria. High ITN coverage is needed to reduce transmission. Mass distribution campaigns are the fastest way to rapidly scale up ITN coverage. However, the best strategy to distribute ITNs to ensure household coverage targets are met is still under debate. This paper presents results from 14 post-campaign surveys in five African countries to assess whether the campaign strategy used had any effect on distribution outcome. METHODS: Data from 13,901 households and 14 campaigns from Ghana, Nigeria, Senegal, South Sudan and Uganda, were obtained through representative cross-sectional questionnaire surveys, conducted three to 16 months after ITN distribution. All evaluations used a multi-stage sampling approach and similar methods for data collection. Key outcomes examined were the proportion of households having received a net from the campaign and the proportion of households with one net for every two people. RESULTS: Household registration rates proved to be the most important determinant of a household receiving any net from the campaign (adjusted odds ratio [OR] 74.8; 95 % confidence interval [CI]: 55.3-101.1) or had enough ITNs for all household members (adjusted OR 19.1; 95 % CI: 55.34-101.05). Factors that positively influenced registration were larger household size (adjusted OR 1.7; 95 % CI: 1.5-2.1) and families with children under five (adjusted OR 1.4; 95 % CI: 1.2-1.6). Urban residence was negatively associated with receipt of a net from the campaign (adjusted OR 0.73; 95 % CI: 0.58-0.92). Registration was equitable in most campaigns except for Uganda and South Sudan, where the poorest wealth quintiles were less likely to have been reached. After adjusting for other factors, delivery strategy (house-to-house vs. fixed point) and distribution approach (integrated versus stand-alone) did not show a systematic impact on registration or owning any ITN. Campaigns that used a universal coverage allocation strategy were more effective in increasing the proportion of households with enough ITNs than campaigns that used a fixed number of ITNs. Registering based on counting usual sleeping spaces resulted in higher levels of households with one net per two people among those receiving any campaign net (adjusted OR 1.6; 95 % CI: 1.07-2.48) than campaigns that registered based on the number of household members. CONCLUSION: All of the campaigns, irrespective of strategy, successfully increased ownership of at least one ITN. Delivery method and distribution approach were not associated with receipt of at least one ITN from the campaign. Rather, the key determining factor for receipt of at least one ITN from the campaign was a successful registration process, which depends on the ability of community volunteers to reach households during the exercise. Universal coverage campaigns, especially those that used a sleeping space allocation strategy, were more effective in increasing the proportion of households with enough ITNs. Maximizing registration completeness and using a universal coverage allocation strategy are therefore likely to improve campaign outcomes.

Systematic review of cross-national drug utilization studies in Latin America: methods and comparability.

PURPOSE: We systematically review the cross-national drug utilization studies performed in Latin America (LA) in order to analyze the methods applied and assess the validity of the data to ensure the comparability. METHODS: A systematic search in Medline, Embase, and BIREME was performed. Drug utilization studies including LA countries and comparing drug exposure data on volume were included. The data validity was judged independently by two authors as having low, medium, high, or unclear risk of bias. RESULTS: Out of 1191 articles, 25 were kept for full text reading. Finally, five studies were selected. Eight different Latin American countries were involved in the comparisons. The selected studies analyzed wholesale data from a private research company collecting information from the private healthcare sector. In three studies, a high risk of bias in the extrapolation method applied was identified. In one study, a risk of data collection bias was detected. The most frequent limitation detected by the original authors was related to the unavailability of information from the public sector in LA. CONCLUSION: Drug utilization studies comparing data cross-nationally are scarce in LA. In general, validity of the comparisons is hampered by a potential risk of extrapolation bias given the lack of available data on drug consumption from the public healthcare sector. Setting up systems to remediate this situation is a future challenge for researchers and (supra)national authorities in the region.

[Proposed model for managing drugs used for unregistered indications in Colombia]. / Propuesta de un modelo de gestión de medicamentos en indicaciones no registradas en Colombia.

The use of drugs for unregistered indications, known as "off-label" use, is a practice that creates problems of rational use and access when other options are not available. Health systems should address this situation, particularly in connection with decisions concerning coverage, while trying to minimize health risks and clearly define the roles and responsibilities of the parties involved. Colombia's Ministry of Health and Social Protection (MinSalud), together with the National University of Colombia and national experts, developed a proposal for a model for managing drugs being used for unregistered indications (off-label) and their potential reimbursement with public resources, taking into account international practices and country characteristics. The management model is non-punitive and is geared toward promoting the rational use of these drugs so that barriers to access are reduced whenever their use is supported by solid scientific evidence. The model addresses patient safeguards in the bioethical domain and the roles and responsibilities of the prescriber and government entities.

Impact of a behaviour change communication programme on net durability in eastern Uganda.

BACKGROUND: The importance of net durability and the average useful life of a net is increasingly recognized as one of the critical factors that determine how often nets need to be replaced. A study to assess the effect of a net care and repair behaviour change communication (BCC) programme on net durability was conducted in one district in Eastern Uganda with a district in a neighbouring region serving as a comparison. Both districts had received LLINs in September of 2012. METHODS: The intervention was comprised of radio programmes, school and community events. Two-stage cluster sampling household surveys to assess net condition, exposure to BCC messages, and attitudes towards net care and repair were conducted in both districts at baseline (2-3 months post net distribution) and endline (20-21 months post distribution). Net condition was assessed using the proportionate hole index, with nets being classified as either serviceable or too torn. RESULTS: The intervention led to an additional 31.2 % increased exposure to net care and repair messages in the intervention district. Respondents in the intervention district had a more positive attitude towards net care and repair (32 % of respondents were classified as having a very positive attitude compared to 10 % in the comparison district), which was positively associated with the number of channels through which messages had been received (P < 0.001). Nets belonging to respondents with a very positive attitude were more often categorized as serviceable (80.2 %) compared to respondents with a poor/average attitude (66.4 %; odds ratio: 2.05, P = 0.028); however, this was only observed for the net brand with the greater physical integrity. Additionally, socio-economic status was a significant predictor of net condition. Although nets in the intervention district had significantly more repairs done per net, the act of repairing alone did not improve net condition. CONCLUSIONS: In conclusion, the evaluation showed that the BCC programme resulted in improved knowledge and attitudes towards care and repair, which impacted positively on net condition. Repairs alone were not sufficient to improve net condition. Additional research on which care behaviours and attitudes are most associated with improved net condition would help BCC planners hone their campaigns.

Impact of a behaviour change intervention on long-lasting insecticidal net care and repair behaviour and net condition in Nasarawa State, Nigeria.

BACKGROUND: While some data on net durability have been accumulating in recent years, including formative qualitative research on attitudes towards net care and repair, no data are available on how the durability of a net is influenced by behaviour of net maintenance, care and repair, and whether behavioural change interventions (BCC) could substantially impact on the average useful life of the net. METHODS: The study used an intervention-control design with before-after assessment through repeated cross-sectional household surveys with two-stage cluster sampling following Nasarawa State's December 2010 mass campaign. All campaign nets were 100-denier polyester, long-lasting insecticidal nets (LLIN). Baseline, midline, and endline surveys occurred at one-year intervals, in March 2012, March 2013, and April 2014, respectively. Outcome measures were the proportion of confirmed campaign nets with observed repairs, and the proportion in serviceable condition, measured with proportionate hole index (pHI) and according to WHO guidelines. RESULTS: For all respondents, exposure to BCC messages was strongly correlated with increased positive attitude towards care and repair, and increases in attitude were positively correlated with observed net repairs, and with the proportion of nets in serviceable condition. In a multivariate regression model, positive care and repair attitude (OR 6.17 p = 0.001) and level of exposure (1 source: OR 4.00 p = 0.000; 3 sources: OR 9.34 p = 0.000) remained the most significant predictors of net condition, controlling for background and environmental factors. Nets that were tied up had 2.70 higher odds of being in serviceable condition (p = 0.001), while repairs made to nets were not sufficient to improve their pHI category. Estimated median net lifespan was approximately one full year longer for nets in households with a positive compared to a negative attitude. CONCLUSION: Exposure to multiple channels of a comprehensive BCC intervention was associated with improved attitude scores, and with improved net condition at endline. It is possible for BCC interventions to change both attitudes and behaviours, and to have an important effect on overall median net lifespan. Care and repair messages are easily incorporated into existing malaria BCC platforms, and will help contribute to improved net condition, providing, in principle, more protection from malaria.

"It is about how the net looks": a qualitative study of perceptions and practices related to mosquito net care and repair in two districts in eastern Uganda.

BACKGROUND: Prolonging net durability has important implications for reducing both malaria transmission and the frequency of net replacement. Protective behaviour, such as net care and repair, offers promise for improving net integrity and durability. Given the potential cost-savings and public health benefit associated with extending the useful life of long-lasting insecticidal nets (LLINs), prevention and mitigation of damage will become ever more critical to ensuring adequate net coverage at the population level. METHODS: A qualitative assessment was conducted in two districts in central eastern Uganda in September 2013. Data on household net care and repair behaviour, attitudes and practices were collected from 30 respondents through in-depth interviews (IDIs), observations, photos, and video to gather an in-depth understanding of these behaviours. RESULTS: Net damage was common and the most cited causes were children and rodents. Responses revealed strong social norms about net cleanliness and aesthetics, and strong expectations that others should care for and repair their own nets. Respondents were receptive and able to repair nets, though longer-term repair methods, such as sewing and patching, were not as commonly reported or observed. Self-reported behaviour was not always consistent with observed or demonstrated behaviour, revealing potential misconceptions and the need for clear and consistent net care and repair messaging. CONCLUSIONS: Respondents considered both aesthetics and malaria protection important when deciding whether, when, and how to care for and repair nets. BCC should continue to emphasize the importance of maintaining net integrity for malaria prevention purposes as well as for maintaining aesthetic appeal. Additional research is needed, particularly surrounding washing, drying, daily storage routines, and gender roles in care and repair, in order to understand the complexity of these behaviours, and refine existing or develop new behaviour change communication (BCC) messages for net care and repair.

"We are supposed to take care of it": a qualitative examination of care and repair behaviour of long-lasting, insecticide-treated nets in Nasarawa State, Nigeria.

BACKGROUND: The longevity of long-lasting insecticidal nets (LLIN) under field conditions has important implications for malaria vector control. The behaviour of bed net users, including net care and repair, may protect or damage bed nets and impact the physical integrity of nets. However, this behaviour, and the motivating and inhibiting factors, is not well understood. METHODS: Qualitative research methods were used to examine behaviour, attitudes and norms around damage, care and repair of LLINs. Eighteen in-depth interviews (IDI) and six focus group discussions (FGD) were conducted with LLIN users in two local government areas of Nasarawa State, Nigeria. A brief background questionnaire with the 73 participants prior to IDIs or FGDs collected additional data on demographics, net use, and care and repair behaviour. RESULTS: Respondents cited that the major causes of damage to bed nets are primarily children, followed by rodents, everyday handling that is not gentle, and characteristics of sleeping spaces. Caring for nets was perceived as both preventing damage by careful handling and keeping the net clean, which may lead to over-washing of LLINs. Repairing a damaged net was considered something that net users should do and the responsibility of adults in the household. Despite this, reported frequency of net repair was low (18%). Motivations for taking care of and repairing nets centred around caring for one's family, avoiding mosquito bites, saving money, and maintaining the positive opinion of others by keeping a clean and intact net. Barriers to net care and repair related to time availability and low perceived value of bed nets or of one's health. CONCLUSION: This study provides novel and valuable insights on the perceptions and attitudes of LLIN users in Nasarawa, Nigeria on the durability of bed nets, how to care for and repair nets, and for what reasons. Communication around net care should stress proper daily storage of nets, regular net inspections, prompt repairs, and clarify misconceptions about proper washing frequency and technique. These messages should include compelling motivators, such as local social norms of household hygiene.

Strategic roles for behaviour change communication in a changing malaria landscape.

Strong evidence suggests that quality strategic behaviour change communication (BCC) can improve malaria prevention and treatment behaviours. As progress is made towards malaria elimination, BCC becomes an even more important tool. BCC can be used 1) to reach populations who remain at risk as transmission dynamics change (e.g. mobile populations), 2) to facilitate identification of people with asymptomatic infections and their compliance with treatment, 3) to inform communities of the optimal timing of malaria control interventions, and 4) to explain changing diagnostic concerns (e.g. increasing false negatives as parasite density and multiplicity of infections fall) and treatment guidelines. The purpose of this commentary is to highlight the benefits and value for money that BCC brings to all aspects of malaria control, and to discuss areas of operations research needed as transmission dynamics change.

Pharmaceutical policies: effects of reference pricing, other pricing, and purchasing policies.

BACKGROUND: Pharmaceuticals are important interventions that could improve people's health. Pharmaceutical pricing and purchasing policies are used as cost-containment measures to determine or affect the prices that are paid for drugs. Internal reference pricing establishes a benchmark or reference price within a country which is the maximum level of reimbursement for a group of drugs. Other policies include price controls, maximum prices, index pricing, price negotiations and volume-based pricing. OBJECTIVES: To determine the effects of pharmaceutical pricing and purchasing policies on health outcomes, healthcare utilisation, drug expenditures and drug use. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), part of The Cochrane Library (including the Effective Practice and Organisation of Care Group Register) (searched 22/10/2012); MEDLINE In-Process & Other Non-Indexed Citations and MEDLINE, Ovid (searched 22/10/2012); EconLit, ProQuest (searched 22/10/2012); PAIS International, ProQuest (searched 22/10/2012); World Wide Political Science Abstracts, ProQuest (searched 22/10/2012); INRUD Bibliography (searched 22/10/2012); Embase, Ovid (searched 14/12/2010); NHSEED, part of The Cochrane Library (searched 08/12/2010); LILACS, VHL (searched 14/12/2010); International Political Science Abstracts (IPSA), Ebsco (searched (17/12/2010); OpenSIGLE (searched 21/12/10); WHOLIS, WHO (searched 17/12/2010); World Bank (Documents and Reports) (searched 21/12/2010); Jolis (searched 09/10/2011); Global Jolis (searched 09/10/2011) ; OECD (searched 30/08/2005); OECD iLibrary (searched 30/08/2005); World Bank eLibrary (searched 21/12/2010); WHO - The Essential Drugs and Medicines web site (browsed 21/12/2010). SELECTION CRITERIA: Policies in this review were defined as laws; rules; financial and administrative orders made by governments, non-government organisations or private insurers. To be included a study had to include an objective measure of at least one of the following outcomes: drug use, healthcare utilisation and health outcomes or costs (expenditures); the study had to be a randomised trial, non-randomised trial, interrupted time series (ITS), repeated measures (RM) study or a controlled before-after study of a pharmaceutical pricing or purchasing policy for a large jurisdiction or system of care. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the risk of bias. Results were summarised in tables. There were too few comparisons with similar outcomes across studies to allow for meta-analysis or meaningful exploration of heterogeneity. MAIN RESULTS: We included 18 studies (seven identified in the update): 17 of reference pricing, one of which also assessed maximum prices, and one of index pricing. None of the studies were trials. All included studies used ITS or RM analyses. The quality of the evidence was low or very low for all outcomes. Three reference pricing studies reported cumulative drug expenditures at one year after the transition period. Two studies reported the median relative insurer's cumulative expenditures, on both reference drugs and cost share drugs, of -18%, ranging from -36% to 3%. The third study reported relative insurer's cumulative expenditures on total market of -1.5%. Four reference pricing studies reported median relative insurer's expenditures on both reference drugs and cost share drugs of -10%, ranging from -53% to 4% at one year after the transition period. Four reference pricing studies reported a median relative change of 15% in reference drugs prescriptions at one year (range -14% to 166%). Three reference pricing studies reported a median relative change of -39% in cost share drugs prescriptions at one year (range -87% to -17%). One study of index pricing reported a relative change of 55% (95% CI 11% to 98%) in the use of generic drugs and -43% relative change (95% CI -67% to -18%) in brand drugs at six months after the transition period. The same study reported a price change of -5.3% and -1.1% for generic and brand drugs respectively six months after the start of the policy. One study of maximum prices reported a relative change in monthly sales volume of all statins of 21% (95% CI 19% to 24%) after one year of the introduction of this policy. Four studies reported effects on mortality and healthcare utilisation, however they were excluded because of study design limitations. AUTHORS' CONCLUSIONS: The majority of the studies of pricing and purchasing policies that met our inclusion criteria evaluated reference pricing. We found that internal reference pricing may reduce expenditures in the short term by shifting drug use from cost share drugs to reference drugs. Reference pricing may reduce related expenditures with effects on reference drugs but the effect on expenditures of cost share drugs is uncertain. Reference pricing may increase the use of reference drugs and may reduce the use of cost share drugs. The analysis and reporting of the effects on patients' drug expenditures were limited in the included studies and administration costs were not reported. Reference pricing effects on health are uncertain due to lack of evidence. The effects of other purchasing and pricing policies are until now uncertain due to sparse evidence. However, index pricing may reduce the use of brand drugs, increase the use of generic drugs, and may also slightly reduce the price of the generic drug when compared with no intervention.

'By seeing with our own eyes, it can remain in our mind': qualitative evaluation findings suggest the ability of participatory video to reduce gender-based violence in conflict-affected settings.

Gender-based violence is pervasive and poses unique challenges in conflict-affected settings, with women and girls particularly vulnerable to its sequelae. Furthermore, widespread stigmatization of gender-based violence promotes silence among survivors and families, inhibiting access to services. Little evidence exists regarding effective gender-based violence prevention interventions in these settings. Through Our Eyes, a multi-year participatory video project, addressed gender-based violence by stimulating community dialogue and action in post-conflict settings in South Sudan, Uganda, Thailand, Liberia and Rwanda. The present qualitative analysis of project evaluation data included transcripts from 18 focus group discussions (n = 125) and key informant interviews (n = 76). Study participants included project team members, representatives from partner agencies, service providers and community members who either participated in video production or attended video screenings. Study findings revealed that the video project contributed to a growing awareness of women's rights and gender equality. The community dialogue helped to begin dismantling the culture of silence gender-based violence, encouraging survivors to access health and law enforcement services. Furthermore, both men and women reported attitude and behavioral changes related to topics such as wife beating, gender-based violence reporting and girls' education. Health education professionals should employ participatory video to address gender-based violence within conflict-affected settings.

Community perspectives on barriers and strategies for promoting locally grown produce from an urban agriculture farm.

Although much is understood about barriers to healthy food consumption in low-income, urban communities, knowledge regarding the crucial next step of building feasible, community-supported approaches to address those barriers remains limited. This qualitative study used in-depth interviews (n = 20), focus groups (n = 2), and participant observations (n = 3) to identify strategies to promote locally grown produce from an urban food security project, Produce From the Park (PFP), an urban farm. Informants included community organization representatives and residents from low-income neighborhoods in a mid-Atlantic city. Informants identified structural and cultural barriers to purchasing healthy food, including price, location, food culture, and lack of interest. Participants proposed a number of strategies, such as distribution through mobile food carts and farm stands, marketing new foods through taste tests and cooking demonstrations, and youth mentorship. Informants also described their perceptions of the local urban farm and suggested ways to increase community buy-in. Strategies mentioned were inexpensive and incorporated cultural norms and local assets. These community perspectives can provide insights for those promoting healthy eating in urban African American communities through urban food security projects.

Developing a modified directly observed therapy intervention for hepatitis C treatment in a methadone maintenance program: implications for program replication.

BACKGROUND: Hepatitis C virus (HCV) is a prevalent chronic blood-borne infection among opioid-dependent patients on methadone maintenance treatment (MMT). Despite case reports and case-control studies, a randomized controlled trial (RCT) examining HCV treatment adherence in methadone-maintained patients is lacking and was the impetus for this ongoing RCT examining modified directly administered therapy for HCV treatment integrated within a MMT. METHODS: Subjects were randomized 1:1 to receive HCV treatment as modified directly observed therapy (mDOT) into the MMT program or at a liver specialty clinic as self-administered therapy (SAT). Randomization was stratified based on HIV status and HCV genotype. RESULTS: Twenty-one subjects to date have enrolled in this pilot study. The mDOT subjects have had greater success in starting treatment and 10 of the 12 mDOT subjects achieved early virologic response (EVR) at week 12 and 6 of those 10 achieved sustained virologic response (SVR). Of the nine SAT subjects, only three achieved EVR at week 12 and only one achieved SVR despite not completing the treatment. CONCLUSIONS: Hepatitis C treatment can be successfully integrated into a methadone maintenance clinic, and mDOT can be implemented with a methadone clinic's existing nursing and medical staff. Patients struggling with concurrent substance use and mental illness comorbidity may be successfully addressed in such settings and facilitate access to and completion of treatment through the utilization of on-site clinical services for HCV treatment and adherence support with mDOT. The exact importance of site of services and adherence support remains a significant area for future investigation.

Transparency of data on the value chain of medicines in Argentina, Brazil, and Colombia.

Introduction: The transparency of data on the value chain of medicines is crucial for the study and monitoring of the pharmaceutical system. These data may impact medicine pricing negotiations, contribute to patient access to pharmaceutical products, and strengthen health systems. Objective: This study analyzed the national strategies to ensure the transparency of data from medicine cost development to marketing in Argentina, Brazil, and Colombia. Method: A descriptive study was carried out by searching databases, reports, documents, and scientific articles published between January and August 2022 related to rules on transparency and databases, including 1) marketing authorization; 2) pricing; 3) intellectual property; 4) clinical trials; 5) research and development (R&D); and 6) health technology assessment (HTA) of selected biopharmaceuticals. Results: Transparency data, rules, and information are not uniform. The infostructures (organizational capacity for collecting and distributing information) regarding the pharmaceutical value chain in these three countries face limitations in appropriate measures to publicly share data and evidence, including pre-clinical data, clinical data, and costs. None of the countries require transparency about data on research and development costs. All three countries present similar publicization of data on marketing authorization and intellectual property, with some differences. The significant limitations in Argentina include the absence of formal price regulation and data on the volume of medicine purchased and respective amounts paid. Among the three countries, Brazil showed a higher degree of information transparency, perhaps due to the legal regulation that guarantees citizens access to information of public interest. Brazil also stands out in terms of the public availability of HTA reports and pricing, in addition to the highest volume of information. In contrast, Colombia has in place a decree that allows 5 years of trial data exclusivity for new medicines, an act contrary to data transparency. Despite the different stages of transparency, no country has evidenced a robust use of these data in public policy decision-making. Conclusion: The results reinforce the presence of information asymmetry between stakeholders, data fragmentation, data gaps and overlap, and difficulty in comparing available data across the three countries and the use of these data nationally to produce evidence.

When Knowledge Is Not Enough: Applying a Behavioral Design Approach to Improve Fever Case Management in Nigeria.

BACKGROUND: We sought to encourage health care providers to adhere to national malaria case management guidelines. This requires them to conduct malaria parasite tests for every patient presenting with a fever and provide malaria treatment only to those who test positive for malaria. Our goal was to make it easier for providers to follow guidelines by addressing drivers of nonadherence uncovered through facility observations and interviews with staff and clients. IMPLEMENTATION AND MONITORING: The case management interventions were piloted in 12 public health facilities in Akwa Ibom, Kebbi, and Nasarawa states in Nigeria between October and December 2019. Participating facilities included 1 hospital and 3 primary health centers in each state. Relevant changes included the following: (1) providers at each facility participated in facilitated discussions to correct misconceptions about the reliability of malaria test kits; (2) testing procedures were integrated into existing triage systems; (3) treatment algorithms were integrated into medical record forms; (4) providers were issued pictorial brochures outlining danger signs to share with clients, together with instructions for when to seek further care; and (5) a process was created for facilities to monitor their own adherence to guidelines. LESSONS LEARNED: The lessons learned include: (1) disentangling the drivers of behavior allows for more targeted solutions, (2) solutions that streamline processes for overburdened providers allow them to redirect their attention and efforts where they can be most impactful, and (3) changing staff perceptions of workplace norms can support a holistic and sustained approach to behavior change.