"Caught In Each Other's Traps": Factors Perpetuating Incentive-Linked Prescribing Deals Between Physicians and the Pharmaceutical Industry.

BACKGROUND: Despite known adverse impacts on patients and health systems, 'incentive-linked prescribing', which describes the prescribing of medicines that result in personal benefits for the prescriber, remains a widespread and hidden impediment to quality of healthcare. We investigated factors perpetuating incentive-linked prescribing among primary care physicians in for-profit practices (referred to as private doctors), using Pakistan as a case study. METHODS: Our mixed-methods study synthesised insights from a survey of 419 systematically samples private doctors and 68 semi-structured interviews with private doctors (n=28), pharmaceutical sales representatives (n=12), and provincial and national policy actors (n=28). For the survey, we built a verified database of all registered private doctors within Karachi, Pakistan's most populous city, administered an electronic questionnaire in-person and descriptively analysed the data. Semi-structured interviews incorporated a vignette-based exercise and data was analysed using an interpretive approach. RESULTS: Our survey showed that 90% of private doctors met pharmaceutical sales representatives weekly. Three interlinked factors perpetuating incentive-linked prescribing we identified were: gaps in understanding of conflicts of interest and loss of values among doctors; financial pressures on doctors operating in a (largely) privately financed health-system, exacerbated by competition with unqualified healthcare providers; and aggressive incentivisation by pharmaceutical companies, linked to low political will to regulate and an over-saturated pharmaceutical market. CONCLUSION: Regular interactions between pharmaceutical companies and private doctors are normalised in our study setting, and progress on regulating these is hindered by the substantial role of incentive-linked prescribing in the financial success of physicians and the pharmaceutical industry employees. A first step towards addressing the entrenchment of incentive-linked prescribing may be to reduce opposition to restrictions on incentivisation of physicians from stakeholders within the pharmaceutical industry, physicians themselves, and policymakers concerned about curtailing growth of the pharmaceutical industry.

What happens when private general practitioners receive incentivisation offers from pharmaceutical sales representatives? A qualitative study in Pakistan.

OBJECTIVES: Pharmaceutical incentivisation of physicians for profit maximisation is a well-documented health system challenge. This study examined general practitioners' (GPs) reactions to pharmaceutical incentivisation offers in one region in Pakistan. METHODS: We used the Standardised Pharmaceutical Sales Representative (SPSR) method and qualitative interviews with GPs. SPSRs were field researchers representing mock pharmaceutical companies who recorded their observations of 267 GPs' responses to pharmaceutical incentivisation offers. We triangulated SPSR data using qualitative interviews with a subset of the same GPs to gather information about how they interpreted different interaction outcomes. RESULTS: We found four major outcomes for GPs being offered incentives by pharmaceutical companies for prescribing medications. GPs might agree to make incentivisation deals, reject incentivisation offers, disallow PSRs to access them, or remain indeterminate with no clear indication of acceptance or rejection of incentivisation offers. GPs rejecting SPSRs' incentivisation offers indicated having active commitments to other pharmaceutical companies, not being able to work with unheard-of companies, and asking SPSRs to return later. CONCLUSIONS: The GP-pharmaceutical sales representative interaction that centres on profit-maximisation is complex as offers to engage in prescribing for mutual financial benefit are not taken up immediately. The SPSR method helps understand the extent of distortion of practices impacted by incentivisation. Such an understanding can support the development of strategies to control unethical behaviours.

Incentivisation practices and their influence on physicians' prescriptions: A qualitative analysis of practice and policy in Pakistan.

Focus on profit-generating enterprise in healthcare can create conflicts of interest that adversely impact prescribing and pricing of medicines. Although a global challenge, addressing the impacts on quality of care is particularly difficult in countries where the pharmaceutical industry and physician lobby is strong relative to regulatory institutions. Our study characterises the range of incentives exchanged between the pharmaceutical industry and physicians, and investigates the differences between incentivisation practices and policies in Pakistan. In this mixed methods study, we first thematically analysed semi-structured interviews with 28 purposively selected for-profit primary-care physicians and 13 medical sales representatives from pharmaceutical companies working across Pakistan's largest city, Karachi. We then conducted a content analysis of policies on ethical practice issued by two regulatory bodies responsible in Pakistan, and the World Health Organization. This enabled a systematic comparison of incentivisation practices with what is considered 'prohibitive' or 'permissive' in policy. Our findings demonstrate that incentivisation of physicians to meet pharmaceutical sales targets is the norm, and that both parties play in the symbiotic physician-pharma incentivisation dynamics. Further, we were able to categorise the types of incentive exchanged into one of five categories: financial, material, professional or educational, social or recreational, and familial. Our comparison of incentivisation practices with policies revealed three reasons for such widespread incentivisation linked to sales targets: first, some clear policies were being ignored by physicians; second, there are ambiguous or contradictory policies with respect to specific incentive types; and third, numerous incentive types are unaddressed by existing policies, such as pharmaceutical companies paying for private clinic renovations. There is a need for policies to be clarified and updated, and to build buy-in for policy enforcement from pharmaceutical companies and physicians, such that transgressions on target-driven prescribing are seen to be unethical.

Antiracism in leading public health universities, journals and funders: commitments, accountability and the decision-makers.

INTRODUCTION: Two years since the murder of George Floyd, there has been unprecedented attention to racial justice by global public health organisations. Still, there is scepticism that attention alone will lead to real change. METHODS: We identified the highest-ranked 15 public health universities, academic journals and funding agencies, and used a standardised data extraction template to analyse the organisation's governance structures, leadership dynamics and public statements on antiracism since 1 May 2020. RESULTS: We found that the majority of organisations (26/45) have not made any public statements in response to calls for antiracism actions, and that decision-making bodies are still lacking diversity and representation from the majority of the world's population. Of those organisations that have made public statements (19/45), we identified seven types of commitments including policy change, financial resources, education and training. Most commitments were not accompanied by accountability measures, such as setting goals or developing metrics of progress, which raises concerns about how antiracism commitments are being tracked, as well as how they can be translated into tangible action. CONCLUSION: The absence of any kind of public statement paired with the greater lack of commitments and accountability measures calls into question whether leading public health organisations are concretely committed to racial justice and antiracism reform.

Socioecological factors linked with pharmaceutical incentive-driven prescribing in Pakistan.

Pharmaceutical marketing through financial incentivisation to general practitioners (GPs) is a poorly studied health system problem in Pakistan. Pharmaceutical incentivisation is seen to be distorting GPs prescribing behaviour that can compromise the health and well-being of patients. We draw on a conceptual framework outlined in the ecological system theory to identify multiple factors linked with pharmaceutical incentivisation to GPs in Pakistan. We conducted qualitative interviews with 28 policy actors to seek their views on the health system dynamics, how they sustain pharmaceutical incentivisation and their effect on the quality of care. Our analysis revealed four interlinked factors operating at different levels and how they collectively contribute to pharmaceutical incentivisation. In addition to influences such as the increasing family needs and peers' financial success, sometimes GPs may naturally be inclined to maximise incomes by engaging in pharmaceutical incentivisation. On other hand, the pharmaceutical market dynamics that involve that competition underpinned by a profit-maximisation mindset enable pharmaceutical companies to meet GPs' desires/needs in return for prescribing their products. Inadequate monitoring and health regulations may further permit the pharmaceutical industry and GPs to sustain the incentive-driven relationship. Our findings have important implications for potential health reforms such as introducing regulatory controls, and appropriate monitoring and regulation of the private health sector, required to address pharmaceutical incentivisation to GPs.

A global analysis of One Health Networks and the proliferation of One Health collaborations.

There has been a renewed focus on threats to the human-animal-environment interface as a result of the COVID-19 pandemic, and investments in One Health collaborations are expected to increase. Efforts to monitor the development of One Health Networks (OHNs) are essential to avoid duplication or misalignment of investments. This Series paper shows the global distribution of existing OHNs and assesses their collective characteristics to identify potential deficits in the ways OHNs have formed and to help increase the effectiveness of investments. We searched PubMed, Google, Google Scholar, and relevant conference websites for potential OHNs and identified 184 worldwide for further analysis. We developed four case studies to show important findings from our research and exemplify best practices in One Health operationalisation. Our findings show that, although more OHNs were formed in the past 10 years than in the preceding decade, investment in OHNs has not been equitably distributed; more OHNs are formed and headquartered in Europe than in any other region, and emerging infections and novel pathogens were the priority focus area for most OHNs, with fewer OHNs focusing on other important hazards and pressing threats to health security. We found substantial deficits in the OHNs collaboration model regarding the diversity of stakeholder and sector representation, which we argue impedes effective and equitable OHN formation and contributes to other imbalances in OHN distribution and priorities. These findings are supported by previous evidence that shows the skewed investment in One Health thus far. The increased attention to One Health after the COVID-19 pandemic is an opportunity to focus efforts and resources to areas that need them most. Analyses, such as this Series paper, should be used to establish databases and repositories of OHNs worldwide. Increased attention should then be given to understanding existing resource allocation and distribution patterns, establish more egalitarian networks that encompass the breadth of One Health issues, and serve communities most affected by emerging, re-emerging, or endemic threats at the human-animal-environment interface.

How prepared is the world? Identifying weaknesses in existing assessment frameworks for global health security through a One Health approach.

The COVID-19 pandemic has exposed faults in the way we assess preparedness and response capacities for public health emergencies. Existing frameworks are limited in scope, and do not sufficiently consider complex social, economic, political, regulatory, and ecological factors. One Health, through its focus on the links among humans, animals, and ecosystems, is a valuable approach through which existing assessment frameworks can be analysed and new ways forward proposed. Although in the past few years advances have been made in assessment tools such as the International Health Regulations Joint External Evaluation, a rapid and radical increase in ambition is required. To sufficiently account for the range of complex systems in which health emergencies occur, assessments should consider how problems are defined across stakeholders and the wider sociopolitical environments in which structures and institutions operate. Current frameworks do little to consider anthropogenic factors in disease emergence or address the full array of health security hazards across the social-ecological system. A complex and interdependent set of challenges threaten human, animal, and ecosystem health, and we cannot afford to overlook important contextual factors, or the determinants of these shared threats. Health security assessment frameworks should therefore ensure that the process undertaken to prioritise and build capacity adheres to core One Health principles and that interventions and outcomes are assessed in terms of added value, trade-offs, and cobenefits across human, animal, and environmental health systems.

The healthcare field as a marketplace: general practitioners, pharmaceutical companies, and profit-led prescribing in Pakistan.

Incentivisation of general practitioners (GPs) by pharmaceutical companies is thought to affect prescribing practices, often not in patients' interest. Using a Bourdieusian lens, we examine the socially structured conditions that underpin exchanges between pharmaceutical companies and GPs in Pakistan. The analysis of qualitative interviews with 28 GPs and 13 pharmaceutical sales representatives (PSRs) shows that GPs, through prescribing medicines, met pharmaceutical sales targets in exchange for various incentives. We argue that these practices can be given meaning through the concept of 'field' - a social space in which GPs, PSRs, and pharmacists were hierarchically positioned, with their unique capacities, to enable healthcare provision. However, structural forces like the intense competition between pharmaceutical companies, the presence of unqualified healthcare providers in the healthcare market, and a lack of regulation by the state institutions produced a context that enabled pharmaceutical companies and GPs to use the healthcare field, also, as space to maximise profits. GPs believed the effort to maximise incomes and meet socially desired standards were two key factors that encouraged profit-led prescribing. We conclude that understanding the healthcare field is an important step toward developing governance practices that can address profit-led prescribing.

Impact of a multifaceted intervention on physicians' knowledge, attitudes and practices in relation to pharmaceutical incentivisation: protocol for a randomised control trial.

INTRODUCTION: In settings where the private sector constitutes a larger part of the health system, profit-gathering can take primacy over patients' well-being. In their interactions with pharmaceutical companies, private general practitioners (GPs) can experience the conflict of interest (COI), a situation whereby the impartiality of GPs' professional decision making may be influenced by secondary interests such as financial gains from prescribing specific pharmaceutical brands. METHODS AND ANALYSIS: This study is a randomised controlled trial to assess the impact of a multifaceted intervention on GPs' medical practice. The study sample consists of 419 registered GPs who own/work in private clinics and will be randomly assigned to intervention and control groups. The intervention group GPs will be exposed to emotive and educational seminars on medical ethics, whereas control group GPs will be given seminars on general medical topics. The primary outcome measure will be GPs' prescribing practices, whereas the secondary outcome measures will be their knowledge and attitudes regarding COI that arises from pharmaceutical incentivisation. In addition to a novel standardised pharmaceutical representatives (SPSR) method, in which field researchers will simulate pharmaceutical marketing with GPs, presurvey and postsurvey, and qualitative interviewing will be performed to collect data on GPs' knowledge, attitudes and practices in relation to COI linked with pharmaceutical incentives. Univariate and multivariate statistical analyses will be performed to measure a change in GPs' knowledge, attitudes and practices, while qualitative analysis will add to our understanding of the quantitative SPSR data. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the Pakistan National Bioethics Committee (# 4-87/NBC-582/21/1364), the Aga Khan University (# 2020-4759-1129) and the London School of Hygiene and Tropical Medicine (# 26506). We will release results within 6-9 months of the study's completion. TRIAL REGISTRATION NUMBER: ISRCTN12294839.

How conflicts of interest hinder effective regulation of healthcare: an analysis of antimicrobial use regulation in Cambodia, Indonesia and Pakistan.

BACKGROUND: There has been insufficient attention to a fundamental force shaping healthcare policies-conflicts of interest (COI). We investigated COI, which results in the professional judgement of a policymaker or healthcare provider being compromised by a secondary interest, in relation to antimicrobial use, thereby illuminating challenges to the regulation of medicines use more broadly. Our objectives were to characterise connections between three groups-policymakers, healthcare providers and pharmaceutical companies-that can create COI, and elucidate the impacts of COI on stages of the policy process. METHODS: Using an interpretive approach, we systematically analysed qualitative data from 136 in-depth interviews and five focus group discussions in three Asian countries with dominant private healthcare sectors: Cambodia, Indonesia and Pakistan. FINDINGS: We characterised four types of connections that were pervasive between the three groups: financial, political, social and familial. These connections created strong COI that could impact all stages of the policy process by: preventing issues related to medicines sales from featuring prominently on the agenda; influencing policy formulation towards softer regulatory measures; determining resource availability for, and opposition to, policy implementation; and shaping how accurately the success of contested policies is reported. INTERPRETATION: Our multicountry study fills a gap in empirical evidence on how COI can impede effective policies to improve the quality of healthcare. It shows that COI can be pervasive, rather than sporadic, in influencing regulation of medicine use, and highlights that, in addition to financial connections, other types of connections should be examined as important drivers of COI.

Variations in regulations to control standards for training and licensing of physicians: a multi-country comparison.

BACKGROUND: To strengthen health systems, the shortage of physicians globally needs to be addressed. However, efforts to increase the numbers of physicians must be balanced with controls on medical education imparted and the professionalism of doctors licensed to practise medicine. METHODS: We conducted a multi-country comparison of mandatory regulations and voluntary guidelines to control standards for medical education, clinical training, licensing and re-licensing of doctors. We purposively selected seven case-study countries with differing health systems and income levels: Canada, China, India, Iran, Pakistan, UK and USA. Using an analytical framework to assess regulations at four sequential stages of the medical education to relicensing pathway, we extracted information from: systematically collected scientific and grey literature and online news articles, websites of regulatory bodies in study countries, and standardised input from researchers and medical professionals familiar with rules in the study countries. RESULTS: The strictest controls we identified to reduce variations in medical training, licensing and re-licensing of doctors between different medical colleges, and across different regions within a country, include: medical education delivery restricted to public sector institutions; uniform, national examinations for medical college admission and licensing; and standardised national requirements for relicensing linked to demonstration of competence. However, countries analysed used different combinations of controls, balancing the strictness of controls across the four stages. CONCLUSIONS: While there is no gold standard model for medical education and practise regulation, examining the combinations of controls used in different countries enables identification of innovations and regulatory approaches to address specific contextual challenges, such as decentralisation of regulations to sub-national bodies or privatisation of medical education. Looking at the full continuum from medical education to licensing is valuable to understand how countries balance the strictness of controls at different stages. Further research is needed to understand how regulating authorities, policy-makers and medical associations can find the right balance of standardisation and context-based flexibility to produce well-rounded physicians.

Improving National Intelligence for Public Health Preparedness: a methodological approach to finding local multi-sector indicators for health security.

The COVID-19 epidemic is the latest evidence of critical gaps in our collective ability to monitor country-level preparedness for health emergencies. The global frameworks that exist to strengthen core public health capacities lack coverage of several preparedness domains and do not provide mechanisms to interface with local intelligence. We designed and piloted a process, in collaboration with three National Public Health Institutes (NPHIs) in Ethiopia, Nigeria and Pakistan, to identify potential preparedness indicators that exist in a myriad of frameworks and tools in varying local institutions. Following a desk-based systematic search and expert consultations, indicators were extracted from existing national and subnational health security-relevant frameworks and prioritised in a multi-stakeholder two-round Delphi process. Eighty-six indicators in Ethiopia, 87 indicators in Nigeria and 51 indicators in Pakistan were assessed to be valid, relevant and feasible. From these, 14-16 indicators were prioritised in each of the three countries for consideration in monitoring and evaluation tools. Priority indicators consistently included private sector metrics, subnational capacities, availability and capacity for electronic surveillance, measures of timeliness for routine reporting, data quality scores and data related to internally displaced persons and returnees. NPHIs play an increasingly central role in health security and must have access to data needed to identify and respond rapidly to public health threats. Collecting and collating local sources of information may prove essential to addressing gaps; it is a necessary step towards improving preparedness and strengthening international health regulations compliance.

Using critical information to strengthen pandemic preparedness: the role of national public health agencies.

COVID-19 has demonstrated that most countries' public health systems and capacities are insufficiently prepared to prevent a localised infectious disease outbreak from spreading. Strengthening national preparedness requires National Public Health Institutes (NPHIs), or their equivalent, to overcome practical challenges affecting timely access to, and use of, data that is critical to preparedness. Our situational analysis in collaboration with NPHIs in three countries-Ethiopia, Nigeria and Pakistan-characterises these challenges. Our findings indicate that NPHIs' role necessitates collection and analysis of data from multiple sources that do not routinely share data with public health authorities. Since initiating requests for access to new data sources can be a lengthy process, it is essential that NPHIs are routinely monitoring a broad set of priority indicators that are selected to reflect the country-specific context. NPHIs must also have the authority to be able to request rapid sharing of data from public and private sector organisations during health emergencies and to access additional human and financial resources during disease outbreaks. Finally, timely, transparent and informative communication of synthesised data from NPHIs will facilitate sustained data sharing with NPHIs from external organisations. These actions identified by our analysis will support the availability of robust information systems that allow relevant data to be collected, shared and analysed by NPHIs sufficiently rapidly to inform a timely local response to infectious disease outbreaks in the future.

What can motivate Lady Health Workers in Pakistan to engage more actively in tuberculosis case-finding?

BACKGROUND: Many interventions to motivate community health workers to perform better rely on financial incentives, even though it is not clear that monetary gain is the main motivational driver. In Pakistan, Lady Health Workers (LHW) are responsible for delivering community level primary healthcare, focusing on rural and urban slum populations. There is interest in introducing large-scale interventions to motivate LHW to be more actively involved in improving tuberculosis case-finding, which is low in Pakistan. METHODS: Our study investigated how to most effectively motivate LHW to engage more actively in tuberculosis case-finding. The study was embedded within a pilot intervention that provided financial and other incentives to LHW who refer the highest number of tuberculosis cases in three districts in Sindh province. We conducted semi-structured interviews with 20 LHW and 12 health programme managers and analysed these using a framework categorising internal and external sources of motivation. RESULTS: Internal drivers of motivation, such as religious rewards and social recognition, were salient in our study setting. While monetary gain was identified as a motivator by all interviewees, programme managers expressed concerns about financial sustainability, and LHW indicated that financial incentives were less important than other sources of motivation. LHW emphasised that they typically used financial incentives provided to cover patient transport costs to health facilities, and therefore financial incentives were usually not perceived as rewards for their performance. CONCLUSIONS: This study indicated that interventions in addition to, or instead of, financial incentives could be used to increase LHW engagement in tuberculosis case-finding. Our finding about the strong role of internal motivation (intrinsic, religious) in Pakistan suggests that developing context-specific strategies that tap into internal motivation could allow infectious disease control programmes to improve engagement of community health workers without being dependent on funding for financial incentives.

How can we improve priority-setting for investments in health research? A case study of tuberculosis.

BACKGROUND: Although enhanced priority-setting for investments in health research for development is essential to tackling inequalities in global health, there is a lack of consensus on an optimal priority-setting process. In light of the current surge in tuberculosis (TB) research investment, we use TB as a case study. METHODS: We investigated two critical aspects of a research prioritisation process, namely the criteria that should be used to rank alternative research options and which stakeholders should be involved in priority-setting. We conducted semi-structured interviews with 24 key informants purposively selected from four distinct groups - academia, funding bodies, international policy or technical agencies, and national disease control programmes. Interview transcripts were analysed verbatim using a framework approach. We also performed a systematic analysis of seven diverse TB research prioritisation processes. RESULTS: There was consensus that well-defined and transparent criteria for assessing research options need to be agreed at the outset of any prioritisation process. It was recommended that criteria should select for research that is likely to have the greatest public health impact in affected countries rather than research that mainly fills scientific knowledge gaps. Some interviewees expressed strong views about the need - and reluctance - to make politically challenging decisions that place some research areas at a lower priority for funding. The importance of taking input from stakeholders from countries with high disease burden was emphasised; such stakeholders were notably absent from the majority of prioritisation processes we analysed. CONCLUSIONS: This study indicated two critical areas for improvement of research prioritisation processes such that inequalities in health are better addressed - the need to deprioritise some research areas to generate a specific and meaningful list for investment, and greater involvement of experts working in high disease-burden countries.

Is the current surge in political and financial attention to One Health solidifying or splintering the movement?

INTRODUCTION: The global health field has witnessed the rise, short-term persistence and fall of several movements. One Health, which addresses links between human, animal and environmental health, is currently experiencing a surge in political and financial attention, but there are well-documented barriers to collaboration between stakeholders from different sectors. We examined how stakeholder dynamics and approaches to operationalising One Health have evolved further to recent political and financial support for One Health. METHODS: We conducted a mixed methods study, first by qualitatively investigating views of 25 major policymakers and funders of One Health programmes about factors supporting or impeding systemic changes to strengthen the One Health movement. We then triangulated these findings with a quantitative analysis of the current operations of 100 global One Health Networks. RESULTS: We found that recent attention to One Health at high-level political fora has increased power struggles between dominant human and animal health stakeholders, in a context where investment in collaboration building skills is lacking. The injection of funding to support One Health initiatives has been accompanied by a rise in organisations conducting diverse activities under the One Health umbrella, with stakeholders shifting operationalisation in directions most aligned with their own interests, thereby splintering and weakening the movement. While international attention to antimicrobial resistance was identified as a unique opportunity to strengthen the One Health movement, there is a risk that this will further drive a siloed, disease-specific approach and that structural changes required for wider collaboration will be neglected. CONCLUSION: Our analysis indicated several opportunities to capitalise on the current growth in One Health initiatives and funding. In particular, evidence from better monitoring and evaluation of ongoing activities could support the case for future funding and allow development of more precise guidelines on best practices.