A proposal for an evaluation model of pharmaceutical services for malaria

Malaria is a serious public health problem in over 90 countries worldwide. In Brazil the disease is prevalent in the Amazon and the control rationale is based on early diagnosis and treatment. Quality pharmaceutical services are considered a key element for control. A proposal for evaluating pharmaceutical services for malaria is presented here. A theoretical outline composed of a logical model and an indicator framework is discussed and strives to establish a basis for assessment and judgment of the way in which these services are actually delivered. The aim is to contribute to the understanding of pharmaceutical services for malaria and other endemic diseases, complying with the directives of the Brazilian National Medicines Policy. Pharmaceutical Services; Malaria; National Drug Policy Introduction Malaria is a disease limited to tropical and subtropical areas and a serious public health problem in over 90 countries. Some 515 million cases occur annually, causing 1.5 to 2.7 million deaths worldwide, mainly among children under five years of age and pregnant women 1. In Brazil, the National Malaria Control Program (PNCM) acknowledged 540,047 cases in 2006, of which more than 99% were from the Amazon region. Spatial distribution is heterogeneous, however. The overwhelming majority of cases happen in the states of Amazonas, Rondônia, Pará and Acre 2. The rationale for malaria control in the country is anchored on early diagnosis and adequate treatment. Treatment is specific for the type of malaria and is based on different phases of the parasite cycle 2. This leads to complex treatment regimens that include multiple drugs in various combinations and which are applicable to a variety of patients – adults, the elderly, pregnant women and children of different ages. The Brazilian National Medicines Policy (PNM) lists pharmaceutical services as one of its eight directives and four priorities 3. The main objectives of pharmaceutical services are to supply quality medicines while guaranteeing their rational use. Because activities pertaining to pharmaceutical services are linked to produce measurable management and clinical outcomes, NOTA RESEARCH NOTE Osorio-de-Castro CGS et al. 2076 Cad. Saúde Pública, Rio de Janeiro, 25(9):2075-2082, set, 2009 the different elements of pharmaceutical services (such as the organization of services, prescribing and dispensing) are deemed to have important consequences for the adherence to treatment, both by health professionals, who prescribe and dispense, as well as by patients. Therapeutic success will, in turn, influence disease prevalence in endemic areas and drug resistance. This paper aims to propose a pharmaceutical services evaluation model for endemic diseases in the Brazilian Amazon. To our knowledge the literature has not produced an evaluation model for pharmaceutical services specifically related to endemic diseases. The development of a model based on malaria may be useful to other endemic diseases that share the same control rationale and corroborates the standards stated in the PNM.


Introduction
Malaria is a disease limited to tropical and subtropical areas and a serious public health problem in over 90 countries.Some 515 million cases occur annually, causing 1.5 to 2.7 million deaths worldwide, mainly among children under five years of age and pregnant women 1 .
In Brazil, the National Malaria Control Program (PNCM) acknowledged 540,047 cases in 2006, of which more than 99% were from the Amazon region.Spatial distribution is heterogeneous, however.The overwhelming majority of cases happen in the states of Amazonas, Rondônia, Pará and Acre 2 .
The rationale for malaria control in the country is anchored on early diagnosis and adequate treatment.Treatment is specific for the type of malaria and is based on different phases of the parasite cycle 2 .This leads to complex treatment regimens that include multiple drugs in various combinations and which are applicable to a variety of patients -adults, the elderly, pregnant women and children of different ages.
The Brazilian National Medicines Policy (PNM) lists pharmaceutical services as one of its eight directives and four priorities 3 .The main objectives of pharmaceutical services are to supply quality medicines while guaranteeing their rational use.Because activities pertaining to pharmaceutical services are linked to produce measurable management and clinical outcomes, Cad.Saúde Pública, Rio de Janeiro, 25 (9):2075-2082, set, 2009 the different elements of pharmaceutical services (such as the organization of services, prescribing and dispensing) are deemed to have important consequences for the adherence to treatment, both by health professionals, who prescribe and dispense, as well as by patients.Therapeutic success will, in turn, influence disease prevalence in endemic areas and drug resistance.
This paper aims to propose a pharmaceutical services evaluation model for endemic diseases in the Brazilian Amazon.To our knowledge the literature has not produced an evaluation model for pharmaceutical services specifically related to endemic diseases.The development of a model based on malaria may be useful to other endemic diseases that share the same control rationale and corroborates the standards stated in the PNM.

Methods
A search of two literature databases, SciELO and PubMed, for the period January 1980 to December 2005 was conducted to investigate published information on prescribing, dispensing and adherence to malaria treatment.
Other studies on malaria treatment interventions, and further documentation of international organizations such as Management Sciences for Health (MSH), the World Health Organization (WHO), the Pan American Health Organization (PAHO) and the Amazon Antimalarials Surveillance Network (RAVREDA) were also collected.
A specialist panel, composed of researchers in pharmaceutical services and malaria, drafted the theoretical outline.A logical model was prepared, considering the following evaluation components: context, services organization and logistics, prescribing, dispensing and adherence to treatment.They were then organized according to their specific resources, activities, products and expected results.
Based on this framework, indicators for each component were identified.The issue was to consider mainly published validated indicators, in order to increase external validity.In some cases a measure of adaptation was deemed necessary.The choice of indicators was also influenced by the availability of data from the Brazilian Census Bureau (IBGE), the Brazilian Health Information System (DATASUS), the Brazilian Primary Healthcare Database (SIAB) and the Brazilian Epidemiologic Surveillance Database (SIVEP).Indicators were directed towards investigation of municipalities and health facilities within municipalities.

Results and discussion
The results of this proposal are the logical model and the indicator framework.
The logical model is shown in Table 1.It is organized to characterize inter-component relationships and the influence components have on pharmaceutical services outcomes.
It proposes four components, listing necessary resources for activities to be carried out, expected products for the activities and the evaluation outcomes.Adherence to treatment was understood to be a comprehensive result of all components.Components are referred to in studies on adherence where, in addition to the organization of services and context, prescribing and dispensing are considered as determinants for this outcome 4 .
Adequate organization of services offers a necessary structure for the clinical phases of pharmaceutical services, in health facilities and systems 5 , because drug supply and drug quality are key elements in treatment-based control models, where expected effectiveness is mandatory for success 6 .Since malaria regimens combine various medicines, all must be equally available for first-line and alternative treatments.
The prescription is an important document, used by prescribers, dispensers and other health workers for guidance on treatment 4 .The lack of prescriptions or written instructions is viewed, by those who consider adherence to represent the patient's informed consciousness, to be a true impeditive for its occurrence 7 .
Dispensing must also present specific characteristics such as prescription checking, counseling on drug administration and use, home storage conditions, adverse effects, preventive measures and follow-up.Dispensing promotes adherence and is, in the lack of household care strategies, the last opportunity of interaction between the health system and the out-patient.
Risk-minimization during therapy is associated with quality prescribing and dispensing.In the case of malaria, misunderstanding the complexity of treatment, as well as the onset of severe adverse effects and resistance, causing and stemming from treatment abandonment, may be interpreted as consequences of faulty counseling 4 .
Adherence is the result of a process involving successive institutional and individual responsibilities.Acceptance of therapeutic guidelines by health professionals is considered to be a necessary pre-condition for patient involvement in treatment.Household follow-up is a powerful incentive to adherence outcomes 4 .In the Brazilian Amazon a theoretical 98% of municipalities are Table 1 Logical model for evaluation of pharmaceutical services for uncomplicated malaria in the Brazilian Amazon.

Resources
Activities Products Results served by the Community Health Workers Program (PACS) or Family Health Program (PSF) 8 .Relationships between prescribing, dispensing and adherence in the context of malaria need to be studied not only because cure depends on drug therapy, but also because presumptions and practices may be misconstrued, indicating the need for intervention strategies to correct outcomes 9 .

Budget
The logical model gave rise to the indicator framework.Each component and sub-component was translated into one or more indicators, in order to consolidate the evaluation proposal.One guiding option was the listing of the smallest possible number of indicators.This course of action was taken in order to balance the model's theoretical consistency on one hand and the feasibility of the evaluation process on the other.
Twenty-five indicators were considered (Table 2).Sources included information databases, MSH, the PNCM and the literature 2,4,5,10,11,12,13 , and some had to be adapted to reflect the context and focus of the evaluation process, namely pharmaceutical services for malaria.
There is no specific way to conduct an evaluation of health services.Each proposal is somewhat dependent on the object under assessment and on the standpoint of the evaluating team 14 .This proposal intends to cluster elements of a normative assessment and of evaluation research, confronting the model with the reality of care in a "natural environment" in order to determine what is acceptable within existing parameters of care.Because investigative methods and instruments must reflect the true nature of the subject under investigation, evaluation research is useful in determining not only priorities for assessment but the best possible strategies for implementing them 9 .
It is not possible to abandon the theoretical basis of pharmaceutical services, even if certain criteria may apparently not be applicable to the context of malaria.An example of this issue is the prescription form.Because prescribing for malaria is not usually carried out by physicians, the evaluation proposal was obliged to incorporate context, allowing for the existence of written instructions as an acceptable alternative.This counterbalance between theory and reality eases the evaluation process, albeit limiting its scope.
The therapeutic use of antimalarials may lead to non-adherence, enhancing resistance and disease prevalence.The challenge of pharmaceutical services is to provide services and medicines in order to counter avoidable health problems and help resolve established ones.The development of an evaluation model of pharmaceutical services for malaria can also contribute to the understanding of this key control strategy for other endemic diseases in Brazil.A2 % of patients that declare having completed their treatment in accordance with prescription/written instruction A statistically established fraction of patients interviewed exiting the dispensing area that present a prescription or written instruction, that received a complete treatment regimen, and that live in an accessible location (< 1 hour from the health facility) are followed at household after 2 or 5 days of treatment (depends on regimen).Adherence is assessed through the self-reported method (report of daily treatment progress and experienced problems, including adverse effects).In case of sub-optimal adherence, the patient will be referred back to the health facility Adapted from Osterberg & Blaschke 4 A3 % of patients that at household visit present difference between expected number of pills/capsules (dosage forms) and those actually presented to interviewer A statistically established fraction of patients interviewed exiting the dispensing area that present a prescription or written instruction, that received a complete treatment regimen, and that live in an accessible location (< 1 hour from the health facility) are followed at household after 2 or 5 days of treatment (depends on regimen).The researcher will demand to see the medicines received at encounter to treat malaria.Dosage forms will be counted for comparison with expected number.In case of suboptimal adherence, the patient will be referred back to the health facility

A malária é um grave problema de saúde pública em cerca de 90 países. No Brasil, a Amazônia congrega o maior número de casos. No país, o racional de enfrentamento se baseia em diagnóstico precoce e tratamento. A assistência farmacêutica de qualidade é considerada elemento-chave para o controle da doença. Apresenta-se uma proposta de avaliação da assistência farmacêutica, composta por um modelo lógico e uma grade de indicadores, discutidos de modo a estabelecer uma base de comparação e julgamento da forma na qual os serviços são ofertados. O objetivo é contribuir para o entendimento da assistência farmacêutica na malária e em outras endemias, atendendo às diretrizes da Política
of medicines, adverse effects, and treatment regimen known to patient Complete treatment regimen obtained Adequate patient care Patient follow-up at home Patient and health professional/health worker adherent to treatment/treatment guidelines PNCM: National Malaria Control Program.* In Brazil, malaria treatment is free, 100% fi nanced by the Ministry of Health.Comprehensive result.
Nacional de Medicamentos.Assistência Farmacêutica; Malária; Política Nacional de Medicamentos Contributors C. G. S. Osorio-de-Castro coordinated proposal, development and results, draft and review.G. C. Chaves collaborated on the proposal, development and results, and review.A. M. Ruiz collaborated on the proposal, development and results.E. S. Miranda collaborated on the proposal, development and results, draft and review.M. R. Campos collaborated on the proposal, development, results, and draft.M. C. Suárez-Mútis collaborated on the proposal, development and results, and review.L. F. Freitas collaborated on the proposal, collaborated in development and results.

Table 2
Indicator framework for evaluation of pharmaceutical services for uncomplicated Malaria in the Brazilian Amazon.