Azeredo, Thiago Botelho; Oliveira, Maria Auxiliadora; Santos-Pinto, Cláudia Du Bocage; Miranda, Elaine Silva; Osorio-de-Castro, Claudia Garcia Serpa

doi:10.1590/1413-81232017228.29472016

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ARTICLE • Ciênc. saúde colet. 22 (8) • Ago 2017 • https://doi.org/10.1590/1413-81232017228.29472016 copiar

Sustentabilidade da provisão de medicamentos ARV em países em desenvolvimento: modelo de avaliação com base na história do programa

Autoria SCIMAGO INSTITUTIONS RANKINGS

Resumo

A provisão de medicamentos ARV é central para programas de HIV/Aids, devido a seu impacto no curso da doença e na qualidade de vida. Embora os custos de tratamentos de primeira linha tenham diminuído, os gastos dos programas com os tratamentos tem aumentado a cada ano. A sustentabilidade torna-se fator fundamental para o sucesso dos programas. Um modelo conceitual para avaliação da sustentabilidade da provisão de ARV e instrumentos de coleta de dados foram desenvolvidos. Um estudo piloto foi realizado no Brasil e a pesquisa de campo cobriu Bolívia, Moçambique e Peru. Informantes-chaves foram identificados e entrevistados. Eventos críticos de implementação e rotinização foram investigados na história dos programas. Foi observado maior potencial para sustentabilidade no Peru, onde a provisão está implementada e rotinizada e os gastos são cobertos pelo governo nacional. Em Moçambique, o financiamento da provisão é quase totalmente dependente de ajuda internacional, mas há grandes esforços voltados à expansão da cobertura e rotinização do cuidado a PVH. Na Bolívia, além da dependência externa para o financiamento há problemas de implementação e gerenciamento da provisão. O modelo avaliativo mostrou-se útil na identificação de fatores que influenciam a capacidade para sustentabilidade dos programas nesses países.

Sustentabilidade de programas; HAART; HIV; Aids

Theoretical event* by dimensions	Program operational elements	Investigated topics
Resources
IE – Adequate investment of resources	Trained staff; facilities; financial resources.	•Provide an overview of resources on which the ARV provision has counted on since its beginning: site, infrastructure, volumes and sources of funds •Human resources: how many, training, time commitment •National ARV production •Is coverage adequate?
RE – Stabilization of resources	Clinical protocols; permanent staffing; regular flow of funds.	•Normative regulation of resources and assignment •Coverage Projection •Annual Budget Projection •Resources for ARV provision are part of the amount of resources available to the organization (common fund) •Temporary nature of the contribution and renewal of materials and human resources
Activities
IE – Compatibility of program activities with those of the organization	Similarities between program requirements and organizational capabilities – organization personnel able to fully perform program activities	•What activities are linked to the provision of ARVs? •Who is responsible for these activities? •What was the previous profile (before the provision of ARV) of activities of the implementer (General Office / Department / Ministry of Health)? •New activities (if any) that were introduced in the organization (General Office / Department / Ministry of Health) that are compatible with other activities in practical and technical terms? •Was there discontinuity of the provision of ARV over time? Why?
JIR – Adaptation of activities	Changes to existing protocols and procurement models; competition between existing activities	•What adjustments were necessary to in the implementation of ARV provision over time? •Was there or is there competition among old and new tasks / activities within the implementer, or specific to provision and general to the implementer?
Reinforcement Strategies
JIR – Incentives	Training, salary increases, leadership bonuses, awards to well managed health centers, external incentives for the organization of the program	•Are there incentives such as donation of additional resources, financial or human, for implementation of new activities (provision of ARV)? •Is there a career plan, policy of promoting employees and earnings consistent with activities?
JIR – Transparent Communication	Comprehensive information and surveillance systems; transparency of decision criteria; information feedback; open communication channels	•Are there channels of communication available and known to everyone in the organization? •Is the surveillance and consumption data periodically collected and published? •Are the protocols produced with the participation of physicians? Is there adherence? •How is the communication between the various levels of management?
RE – Risk Taking	Ventures into new ARVs and protocols; procuring through international initiatives; engaging in price negotiations.	•What innovative practices have been brought by the provision for the organization? •Have these innovations been disseminated and incorporated into the organization?
JIR – Integration of Rules	The laws and regulations governing the provision of ARV apply to the rest of the health program	•How do the regulations (norms) of ARVs provision in relation to the rest of the provision of medicines? •Are there rules governing the provision? •Guidelines, protocols, EML (Essential Medicines List)? •Is there integration with the other norms? •Are all these rules known?
Context and Organizational Culture
JIR – Adjustment of goals (Objectives fit)	Adjusted fit vs. discrepancy of goals and purposes between the health system and the provision units	•Is the mission of the provision of ARVs adjusted to the mission of the implementer? •Does the provision of ARV occur in the same way as the provision of medicines in general? •Are there barriers to the provision, which result from the organization of the health system?
JIR – Sharing Cultural Issues	Shared values between program and organization; human rights approach.	•Does the provision of ARVs require specific mechanisms for prescribing, dispensing and health care? •Were health professionals used to work like that? When and in what circumstances? •Are special groups accepted as recipients of care and reached by coverage and therefore by provision?

Bolivia	Mozambique	Peru
Framework Dimension: Resources
The adequate investment of resources (implementation event)
• From the 1990’s to 2007, the country received ARV donations from Brazil; • In 2002 the country starts receiving resources from the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM); • Between 2002 and 2003, 48 treatments are supplied through litigation; • In 2003 US$ 20,000 were allocated for ARV purchase by government; • In 2006, the GFATM grant is renewed.	• A first strategic plan for HIV which dealt with resource investment was established in 1999; • In 2002, the Clinton Foundation (Clinton Health Access Initiative - CHAI) begins supporting the implementation of World Bank and GFATM projects; • Hospitals in Maputo started offering treatment in 2003-04 • In 2003-04 NGOs trained staff and channeled resources for diagnosis in Maputo, Beira, Nampula; • From 2004 to 2009: continuous effort to train health professionals and medical technicians to meet staffing needs for planned care.	• 1995-2000 there was no budget for ARV provision. (out-of-pocket payments for services and medicines); • 2000: a specific budget allocation for ARVs; • 2003: First ARV purchase with GFATM resources, expanding coverage to 3800 PWH; • 2006: MoH becomes responsible for ARV provision (60% of costs). • 2007: Percentage was upped to 70% of costs; • 2008: 100% of costs. Coverage expanded to 14,300 PWH.
Resource stabilization (routinization event)
• GFATM contract since 2002; • GFATM renewed in 2006; • 1990’s -2007 irregular flow of donations from Brazil. (In 2007, donations are discontinued); • 2007: HIV / AIDS law (Law 3729/07); no additional legislation has been passed to make the law operational; there is no guarantee of budget allocation for ARVs; • 2007-2009 many changes in program coordination.	• 2004-08 strategic plan reflects gradual increase-in-coverage choice; • Highly variable flow of resources for AIDS; funding from the GFATM and renewal of WB not guaranteed; • Existence of a common health fund, including human resources and medicine provision for the purchase and distribution of all medicines, including ARVs; • 2006: Brazil (represented by the Oswaldo Cruz Foundation), offers continuous training to health boards, doctors and other professionals.	• 2006-2008, the MoH becomes fully responsible for ARV financing; • 2008: the government changed the type of employment contracts stipulating fixed-term renewable contracts.
Framework Dimension: Activities
Compatibility of program activities with those of the organization (implementation event)
• Lack of technical capabilities for procurement of ARVs by MoH. External agents (CIESS, UNDP, Ibis-Hivos) involved in procurement.	• Since 1999, first MEDIMOC then the Center of Medicines and Medical Items (CMAM) have collaborated with MINSAU routinely with medicines purchases.	• 2003: DIGEMID already exercised provision-related activities such as selection and forecasting for other medicines and became responsible for ARVs; • Procurement, storage and distribution, were taken over by OGA, which already carried out these same activities for other medicines.
Adaptation of activities (joint implementation and routinization event)
• 2004-2006 CIESS involved in ARV provision; • In 2006, after an evaluation by the GFATM, CIESS is removed from activities; • In 2006 UNDP temporarily substitutes CIESS; • In 2006, Ibis / Hivos and PROSALUD are chosen for ARV procurement and distribution activities, after tender carried out in the country. • Since the Ibis / Hivos Foundation began operations, continuity of provision of ARVs can be observed. • With Ibis / Hivos Foundation there was a change in procurement strategies resulting in the introduction of new suppliers and the obtaining of lower prices for ARVs.	• From 2007: responsibility of ARV procurement was transferred from MEDIMOC to CMAM (change of status of MEDIMOC from public to privately-held); • After 2008: the rapid expansion and decentralization of treatment coverage required an upgrade in provincial management and structural capabilities exposing management failures (shortages, surplus stocks and expired medicines).
Framework Dimension: Reinforcement strategies
Incentives (joint implementation and routinization event)
	• There was specific hiring of professionals for purchase ARVs in CMAM; • Until 2008 there were day hospitals, and selective recruitment of physicians for HIV / AIDS care. There were financial resources for extra work, training trips, courses and conferences which led to physicians to desire working exclusively for the program.	• 2008: employees receive career benefits that they did not enjoy previously.
Transparent communication (joint implementation and routinization event)
		• Regular meetings are scheduled between ESN, DIGEMID, OGA and DISA for discussion and planning of ARV selection and forecasting.
Risk Taking (routinization event)
• Innovative procedures in entrance clearance for ARVs have streamlined the release of lots by customs, making it possible to make imported medicines available in 24 hours.	• 2008: the health system has integrated HIV / AIDS care into general health care which requires greater quantity and quality of human resources.	• Since 2003, Peru has participated in ARV price negotiation rounds in order to achieve lower prices and greater coverage. • 2009: Peru has the best buyer profile among Latin America countries.
Integration of rules (joint implementation and routinization event)
	• 2004: official regulations on the use of ARVs were released and all health professionals have to adhere to them. • 2004-2008 :The strategic plan of 2004-08 reinforced the legitimacy of the protocols.	• Since 1997 a succession of laws, edicts and other legislation have regulated HIV/Aids care within the health system.
Framework Dimension: Context and organizational culture
Adjustment of goals/ Objectives fit (joint implementation and routinization event)
	• March 2008: closing of the Day Hospital, replaced by Health Counseling and Testing Service (ATS), for diseases in general, not just AIDS. • 2008: the decision to expand treatment with the definition of the Health Facility network and of treatment goals.	• In 2008, the MoH becomes fully responsible for ARV provision. New duties assigned to existing MoH agencies are synchronic with their institutional missions.
Sharing Cultural Issues (joint implementation and routinization event)
	• 2008: with the closing of the Day Hospitals, many patients felt discriminated against by the newer Health Facilities and left to seek care outside the system.

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[1] Collaborators

All authors participated in study design. TB Azeredo, CDB Santos-Pinto, ES Miranda and CGS Osório-de-Castro conducted data collection and preliminary analysis. TB Azeredo, MA Oliveira and CGS Osório-de-Castro refined analysis and drafted the manuscript. All authors revised the final version of the manuscript.