Exceptional circumstance drug dispensing: history and expenditures of the Brazilian Ministry of Health

OBJECTIVE: To describe the technical aspects of the Exceptional Circumstance Drug Dispensing Program of the Brazilian Ministry of Health, especially with respect to the cost of dispensed medication. METHODS: Technical information was obtained from the ordinances that regulate the Program. Expenditure from 2000 to 2007 was obtained from the Sistema Único de Saúde’s (Unifi ed Healthcare System) Outpatient Information System. All drugs dispensed between 1993 and 2009 and the amount and cost of each procedure were evaluated, based on information from the high-complexity procedure authorization of each of the country’s states. RESULTS: The Program changed with the increase in the number of pharmacological agents and presentations distributed by, and the number of diseases contemplated in the program. In 1993, the program distributed 15 pharmacological agents in 31 distinct presentations. This number increased to 109 agents in 243 presentations in 2009. Total Ministry of Health expenditure with medications was R$1,410,181,600.74 in 2007, almost twice the amount spent in 2000, R$684,975,404.43. Diseases whose expenditure increased in the period included chronic renal insuffi ciency, transplantation, and hepatitis C. CONCLUSIONS: The Exceptional Circumstance Drug Dispensing Program is in constant transformation, aimed at building instruments and strategies that can ensure and expand access to medication among the population. Alternatives should be sought to decrease the fi nancial impact of the Program to a level that does not impact other sectors of the health care system, given the high cost associated with novel interventions. DESCRIPTORS: Exceptional Drugs. Ordinances. Health Expenditures. National Drug Policy.


INTRODUCTION
Pharmaceutical care is part of health care and is critical to the resolution of most diseases. It involves the distribution of a large volume of public resources. a For this reason, increasing access to drugs by the population is one of the great challenges of public policy. 1 In a number of countries, the proportion of total health expenditures related to drug purchases has risen substantially in recent years. In the United Kingdom, the amount of money spent on primary care medications increased by 10% between 2001 and 2002. 3 In Canada, spending increased by 6% in 2006, reaching US$ 25 billion. 2 The United States government estimated that drug-related spending would rise from US$ 184 billion in 2003 to US$ 519 billion in 2013. 4 In Brazil, Ministry of Health (MoH) drug-related expenditures increased by 123.9% between 2002 and 2006, whereas the increase in total health care spending increased by only 9.6% in the same period. b Federal funding of drug purchases is currently regulated by GM ordinance n o. 204, of 29 January 2007, which organized and categorized resources for purchasing these products in the Bloco de Financiamento da Assistência Farmacêutica (Pharmaceutical Care Fund). This fund was divided into three components: basic, strategic, and exceptional circumstance dispensation drugs, c more recently renamed as the "specialized component of pharmaceutical care". d The budget for this last component rose from R$516 million in 2003 to R$1.3 billion in 2006, corresponding to a real value increase of 159%. This program is therefore one of the major components of the increase in drug-related expenditures within the MoH. 5,a In this context, the present article describes the technical aspects of the Exceptional Circumstance Drug Dispensing Program since its creation, in 1982, focusing primarily on the evolution of MoH expenditures on the program.

METHODS
The history of the Exceptional Circumstance Drug Dispensing Program is described based on an analysis of MoH ordinances issued since 1982. In parallel, we carried out a bibliographical survey of the literature on the subject.
Cost analysis began in 2000, the fi rst year for which we were able to obtain complete data on the funds transferred from the MoH to the State Secretariats of Health specifi cally to cover the Program. This year also saw a substantial increase in the number of pharmacological agents and presentations provided free of charge by the MoH. Unifi ed Heath Care System ), run by the MoH. We used outpatient data provided by the Brazilian states to the MoH, given as the "Approved value per year/ competence according to procedure after 10/1999." The "Approved value" item gives the amount of MoH funds allocated, according to the drug expenditures informed by the states through the Autorizações de Procedimento de Alta Complexidade (APAC -High-Complexity Procedure Authorization) registry.
Data for each State/Federation Unit were compiled in electronic spreadsheets for exploratory analysis and, to allow year-to-year comparisons, all values were converted into 2007 prices according to the General Price Index -"Internal availability" of the Fundação Getúlio Vargas.
Demographic data obtained from the DATASUS website were used for per capita expenditure analysis, comparing the population of each state and Region with the amount spent on medication through the Program.
MoH fund allocations were also analyzed to verify the price paid for each drug in the program, thus calculating the approximate expenditure on certain diseases covered by the Program as well as the fraction of total spending attributable to these conditions and the spatial distribution of these values. To this end, we added the amounts spent on all drugs used to treat a given disease based on SIA/SUS data. In parallel, we calculated the fraction of funds spent on this disease in comparison to the total expenditures of the Program.

RESULTS
The Exceptional Circumstance Drug Dispensing Program began to function in 1982, and provides drugs for the treatment of specifi c diseases that affect a limited number of patients. In most cases, these drugs are for long-term use. e Until 1993, the Program provided medication to transplant and chronic renal disease patients. In 1993, the current format of the Program began to be implemented, which included a list of 15 drugs in 31 formulations. c In 1996, SAS/MoH ordinance no. 204 established regulations aimed at increasing MoH control over expenditures. This ordinance created codes in the SIA/SUS table that allowed for computerization of the drug dispensing process, created a form for requesting exceptional circumstance drugs, and updated the list of drugs distributed free of charge by the Program. a In July 1999, Joint SE/SAS/MoH ordinance no. 14 regulated the fi nancing and distribution of resources for drug purchasing within the Program, and one month later, SAS/MoH ordinance no. 409 implemented the APAC system for reimbursing the costs of Program drugs. Thus, in order to facilitate the implementation of drug dispensing control through APAC, the MoH established codes for each drug type, individualized user control through the Cadastro Nacional de Pessoa Física (CPF -National Natural Person Registry), mandated the use of the International Classifi cation of Diseases (ICD), and defi ned the maximum amount of medication to be dispensed per request, among other measures. a Until this time, there were no specifi c norms regulating the inclusion or exclusion of drugs provided by the Program, nor was there an explicit set of technical criteria to be used. All drug inclusions were based on technical evaluations elaborated by consultants hired by the MoH. During this period, patient advocacy groups -perhaps due to their greater political consciencemobilized themselves to support the inclusion and maintenance in the list of drugs of their interest. The selection of drugs into the Program was thus driven by pressure from these groups, which had the support of corporations and other social organizations. c In addition, a number of medications and diseases were either included or excluded from the Program (Table  1), new forms were created for requesting the drugs distributed by the State Departments of Health, and several of the existing protocols were revised.
As a consequence of these modifi cations, many diseases previously not treatable through SUS were included in the Program throughout the years. Coverage thus increased from three major disease classes (transplants, chronic renal insuffi ciency, and hypophyiseal dwarfi sm) to 288 chronic diseases, classifi ed according to ICD-10.
Currently, the incorporation of new drugs into the Program is required to follow the principles of evidence-based medicine. Petitioners must now present studies demonstrating a drug's effi cacy and safety, as well as the advantages of this drug over the available therapeutic options (greater effi cacy or safety or lower cost) or offer the opportunity for competition within a drug subgroup as a market regulatory strategy. e  Figure 1).

Program Expenditures
In all of the country's regions, the per capita increase was smaller than the increase in total annual drugrelated spending. Analysis of annual per capita expenditure in each region shows that, during the studied period, expenditures were consistently higher in the Southeast Region, increasing form R$ 5.69 in 2000 to R$ 11.00 in 2007. During the same period, the North Region consistently showed the lowest per capita expenditure: R$ 1.14 in 2000 to R$ 1.80 in 2007. These same two regions (Southeast and North) also showed the largest and smallest total annual expenditure on medications in the Program, respectively.  Year Annual expenditure (in Reais)  Table 4).

DISCUSSION
The Exceptional Circumstance Drug Dispensing Program has undergone major changes, both technical and administrative in nature.
This Program, initially designed to cover a small and specifi c portion of the population affl icted by diseases regarded as "exceptional," had to come to terms with the brisk technical-scientifi c evolution of global health care throughout the years, ultimately becoming a gateway for the introduction of novel drugs developed for the treatment of diseases not yet covered by SUS. Such transformation becomes obvious when considering the number of pharmacological agents and formulations distributed by the program, which increased approximately 8-fold in nine years.
The transformation of the Program has been largely benefi cial to the Brazilian population, granting free access to treatment of a number of life-threatening diseases. These changes were also benefi cial to the Program's administrative structure, for they helped to create rules for the inclusion of drugs into the Program as well as for their subsequent distribution, providing both the MoH (the funding source) and the states (funding sources and distributors) with more complete and secure systems for information control.
However, as with any new technology, novel drugs arrive at the market with high price tags, and the inclusion of such drugs in the Program has had a large impact on MoH expenditure, as shown in the present study. Thus, an issue of fundamental importance to managers and the technical team is the defi nition of which drugs within a given therapeutic category should be provided by the Program for the treatment of a given disease. Considering the Public Health goal of ensuring the best possible care for the majority of the population, and given that resources for achieving this goal are fi nite, detailed evaluation becomes increasingly necessary. More cost-effective alternatives must be sought in order to promote more rational use of exceptional drugs. Properly choosing a few, effective drugs will open space for the inclusion of other drugs for diseases not yet covered by SUS.
The MoH has been able to rationalize the use of these novel technologies through the publication of the Clinical Protocols and Therapeutic Directives.
However, the current scenario is that system users, physicians, pharmaceutical companies, and the Judiciary pressure the MoH to include new drugs in the Program as soon as these appear on the market. Individuality is being placed above collectivity, hampering efforts to organize the service.
An analysis of the inclusion and exclusion of pharmacological agents showed that very few drugs were excluded from the program after their initial introduction. In the pharmaceutical fi eld, as in many other health-related areas in Brazil, there is a lack of an infrastructure for monitoring the use of a new technology in order to make a decision on continuing or abandoning its use. This is in spite of this stage being known to be as important as implementation, since it can prevent the unnecessary maintenance of an ineffective drug, creating space for the inclusion of others.
To evaluate the exclusion of an item from the list of medications provided by the Program does not necessarily mean to terminate the distribution of this item through SUS. Rather, such evaluation is aimed at assigning the distribution of a drug to the appropriate level of health care given the prevalence of the disease which it is meant to treat. Achieving this goal was the motivation behind MoH ordinance no. 2,981, which mandates that drugs aimed at treating diseases that currently affect a large portion of the population -such as dyslipidemia, hypothyroidism, and osteoporosis -now be distributed through the primary health care network.
This ordinance will also bring about changes in the profi le of expenditures with this component of pharmaceutical care, since now the three spheres of government (Federal, state, and municipal) are responsible for fi nancing specifi c groups of medications.
As to differences in terms of funding between the country's regions and states, it is important to point out that the MoH does not determine the sum to be allocated. Rather, funds are allocated according to what each State reports through APAC -that is, it is the demand of the population that determines the amount spent on Program drugs. Together with the data presented above, this suggests that, in spite of its growth throughout the country, there are still differences in knowledge of and access to the Program between the Brazilian Regions and between states within the same region.
In conclusion, we have shown that the Specialized Component of Pharmaceutical Care is a key part of Brazilian Public Health policy, allowing access to drugs for the treatment of highly complex diseases at the same time as it accounts for a substantial fraction of the budget of the different spheres of government. For this very reason, the Program should remain in constant transformation in order increase access of the population to health care services and to fi nd therapeutic alternatives capable of reducing the fi nancial impact of drug purchases on other areas of Public Health.