Malaria is more prevalent today and the death toll is on the increase annually. It is one of the leading causes of morbidity and mortality worldwide and most of these deaths are in the poorest regions of the world. About 500 million cases are reported annually with more than 2 million deaths, and most are children. It is the major killer in the tropics and a major public health problem in developing countries and Papua New Guinea (PNG) is no exception. Resistant strains have been reported. This may be enhanced by inappropriate human behaviour in the use of anti-malarial drugs. Human factors include inappropriate prescribing and patient behaviour in using anti-malarial drugs. Despite the establishment of the standard treatment guidelines for malaria in PNG, three out of every four patients have chloroquine-resistant falciparum malaria and malaria remains a major health problem. The aim of this study was to evaluate the influence of an education program on patients carers' understanding and effective use of anti-malarial drugs for the treatment of uncomplicated malaria in children in general health clinics in PNG. The trial design involved a pre-post intervention study with a control group. The study was undertaken in the National Capital District. Papua New Guinea using one Clinic as the intervention site and another as the control site. The two clinics were similar in characteristics as confirmed in the study by demographic data where there were no significant differences observed. The data collection took placed over the period February to April 2002. It included observation of drug provision at study sites and interviews of patient carers on the first day at the clinic and a follow up seven days later. Three questionnaires were developed to evaluate the process and outcomes of malaria drug treatment in the above health facilities. / Prescribing data were collected from prescriptions and patient carers' interviewed prior to the intervention program. Following the provision of drug information to patient carers. similar drug information and compliance questioning was undertaken. Differences in the pre-post elements of the study and in the control group over the study period were evaluated using Chi-Squared, Kruskal-Wallis, Fisher's Exact or Student's t-tests as appropriate. In excess of 100 patients in the pre- and in the post intervention phases were evaluated for their understanding and effective use of the anti-malarial drugs. In addition, 100 clients were in the control group at another clinic. Patients had attended the clinic up to 8 times in the previous year with a median of 2 visits. Amodiaquine, Fansidar, albendazole and paracetamol made up a total of 60% of the drugs prescribed. The use of medicines was strongly supported with 94.4% indicating no problems with the medication. Only 3% of patients received herbal or local remedies for malaria treatment. 1n patients 10 years or less or their carers, it was found, there was a significant improvement in the carers understanding of the medications. There was a statistically significant improvement in patient outcomes from 57.9% to 92.3% reported as cured following the intervention program. The study has also identified low levels of appropriate administration of antibiotic suspensions in children by patient carers. / For example, incorrect responses recorded for amoxycillin suspension were 80.8% (143). Septrim tablets 92% (23), Septrim suspension 86% (123), erythromycin suspension 100% (26), and chloramphenicol suspension 84.4% (38). In this study the face to face (one-to-one) education program was used to influence patient carers understanding and effective use of drugs. The intervention program involved advising, informing, encouraging, and counselling the patient carers verbally on the appropriate and effective use of medicines. The verbal message was reinforced by a suitable label typed in English and Pidgin-English where instructions were clear, simple and unambiguous. The label was then attached to the envelopes or containers containing the drugs. On feedback, the information on the understanding and effective use of drugs was re-emphasized to the carers to reinforce their understanding for future references. Results showed that the intervention program made an impact in improved patient carers understanding and effective use of drugs and children's health outcomes. In conclusion, it is evident that a patient intervention program designed to improve the dosages and frequency of administration of anti-malarial drugs in PNG had no statistically significant outcome. This may be because the current level of understanding was quite high (>70%) and the study experienced a ceiling effect. However, as shown in the results, the patient carers understanding on the appropriate and effective use of drugs was lower during the pre-intervention and control group. / When compared clinic-pre with clinic-post, there was a significant difference (P < 0.05) in the cured group and the improved cure rate increases from 57.9% to 92.3%. When compared control pre with control post groups, there was no significant difference (P > 0.05) in the cured group. Therefore, the study identified an improvement in patient outcomes with respect to malaria. Hence. the simple intervention program in influencing patient carers understanding of the appropriate and effective use of medications led to a marked improvement in patient outcomes.

Abtract Charles University Faculty of Pharmacy in Hradec Králové Department of Social and Clinical Pharmacy Title of diploma thesis: The analysis of self-medication with antibiotics in Kaliningrad region - pilote study Student: Kira Matveicheva Supervisor: prof. PharmDr. Jiří Vlček, Ph.D. Consultant: Tatiana Belkina, Ph.D. Objectives: In the theoretical part, I will focus on the self-medication with antibiotics, including its causes and consequences, and the problems associated with the emergence of antibiotic resistance. The aim of the practical part is to analyze the probability and reasons of self-medication with antibiotics in the Kaliningrad region. Methods: A study was conducted from July-August 2015 of community pharmacists and pharmaceutical assistants in Kaliningrad region, Russia. The theoretical part contains a literature research about self-medication with antibiotics and antibiotic resistance which was performed through using PubMed. The main keywords which were used were: "self- medication; antibiotics use; antimicrobial resistance". In practical part was used a self- administered questinnaire to assess antibiotic dispensing without a medical prescription by pharmacists/ pharmaceutical assistants and causes of self-medication practices. Results: Eighty questionnaires were completed, with a...

O setor farmacêutico brasileiro tem passado por importantes transformações nos últimos anos, entre elas a aprovação da Política Nacional de Medicamentos (PNM), a criação da Agência Nacional de Vigilância Sanitária (Anvisa), a publicação da Lei de Genéricos e a aprovação da Política Nacional de Assistência Farmacêutica (PNAF). Considerando que alguns dos objetivos da PNM são o acesso que propõe disponibilidade equitativa e acessibilidade; a qualidade, segurança e eficácia e o uso racional relativos à medicamentos, é que houve a iniciativa do governo brasileiro em implementar uma estratégia na área de políticas de saúde, o fracionamento de medicamentos. Este estudo procura analisar a implementação desta estratégia e o seu decurso de 2005 a 2009, tendo como objetivos: 1) compará-lo com as propostas preconizadas pela PNM e PNAF; 2) promover um panorama do desenvolvimento e das ações atualmente realizadas; 3) refletir em conjunto com as ações desenvolvidas no Brasil nos últimos anos para a promoção do acesso e uso racional de medicamentos. Foi realizada uma pesquisa do tipo análise documental e bibliográfica por meio de um estudo sistematizado desenvolvido a partir de material bibliográfico, documentos e legislações na área de medicamentos, fazendo alusão às políticas e aos aspectos regulatórios do setor farmacêutico no Brasil. O fracionamento de medicamentos foi discutido por meio da construção normativa a partir de referencial cronológico suscitando perspectivas da visão do governo brasileiro. Com dados dos registros de medicamentos fracionáveis, foram traçadas algumas observações acerca do planejamento e desenvolvimento das ações regulatórias. Alterações na cadeia do medicamento, considerando a realidade brasileira, demonstram que qualquer implantação de novas formas de fabricar, comercializar, prescrever, dispensar e utilizar medicamentos, não se efetivará simplesmente com atos regulamentares aplicados isoladamente. A adesão e desenvolvimento desta estratégia por parte de todos os atores envolvidos requer tempo, ações abrangentes, objetivas e coesas com as diretrizes das políticas norteadoras. / The Brazilian pharmaceutical industry has been changing considerably throughout last years. It could be mentioned, as the most important changes ocurred, the approval of National Drugs Policy (PNM), the creation of The National Agency of Health Surveillance (Anvisa), the publishing of Generic Drugs Law and the approval of National Pharmaceutical Assistance Policy (PNAF). Taking into consideration that some goals of PNM are the access that propose fair availability and accessibility to medicines; its quality, safety and effectiveness and its rational use, the brazilian government had the initiative of implementing a strategy on public policies: the drugs fractionation. This study intends to analyze the mentioned strategy implement on its course from 2005 to 2009, and it has the following objectives: 1) Compare it to the proposes suggested by the PNM and PNAF; 2) Promote an overview of the development and actions currently realized; 3) To reflect together with the actions developed in Brazil in recent years to promote access and rational use of medicines. We searched the type documentary analysis and literature through a systematic study developed out of publications, documents and legislation in the field of drugs, referring to policies and regulatory aspects of the pharmaceutical sector in Brazil. Fractionation of drugs was discussed by building normative reference from raising chronological perspective view of the Brazilian government. Through data based on registers publications of fractionated medicines, some observations concerning development of regulatory actions have been made. Changes in the drug chain, considering the Brazilian reality show that any deployment of new forms of manufacturing, selling, prescribing, dispensing and using drugs, not simply to become effective regulatory actions applied alone. Membership and development of this strategy by all stakeholders requires time, actions comprehensive, objective and coherent with the guidelines of the policies guiding.

O setor farmacêutico brasileiro tem passado por importantes transformações nos últimos anos, entre elas a aprovação da Política Nacional de Medicamentos (PNM), a criação da Agência Nacional de Vigilância Sanitária (Anvisa), a publicação da Lei de Genéricos e a aprovação da Política Nacional de Assistência Farmacêutica (PNAF). Considerando que alguns dos objetivos da PNM são o acesso que propõe disponibilidade equitativa e acessibilidade; a qualidade, segurança e eficácia e o uso racional relativos à medicamentos, é que houve a iniciativa do governo brasileiro em implementar uma estratégia na área de políticas de saúde, o fracionamento de medicamentos. Este estudo procura analisar a implementação desta estratégia e o seu decurso de 2005 a 2009, tendo como objetivos: 1) compará-lo com as propostas preconizadas pela PNM e PNAF; 2) promover um panorama do desenvolvimento e das ações atualmente realizadas; 3) refletir em conjunto com as ações desenvolvidas no Brasil nos últimos anos para a promoção do acesso e uso racional de medicamentos. Foi realizada uma pesquisa do tipo análise documental e bibliográfica por meio de um estudo sistematizado desenvolvido a partir de material bibliográfico, documentos e legislações na área de medicamentos, fazendo alusão às políticas e aos aspectos regulatórios do setor farmacêutico no Brasil. O fracionamento de medicamentos foi discutido por meio da construção normativa a partir de referencial cronológico suscitando perspectivas da visão do governo brasileiro. Com dados dos registros de medicamentos fracionáveis, foram traçadas algumas observações acerca do planejamento e desenvolvimento das ações regulatórias. Alterações na cadeia do medicamento, considerando a realidade brasileira, demonstram que qualquer implantação de novas formas de fabricar, comercializar, prescrever, dispensar e utilizar medicamentos, não se efetivará simplesmente com atos regulamentares aplicados isoladamente. A adesão e desenvolvimento desta estratégia por parte de todos os atores envolvidos requer tempo, ações abrangentes, objetivas e coesas com as diretrizes das políticas norteadoras. / The Brazilian pharmaceutical industry has been changing considerably throughout last years. It could be mentioned, as the most important changes ocurred, the approval of National Drugs Policy (PNM), the creation of The National Agency of Health Surveillance (Anvisa), the publishing of Generic Drugs Law and the approval of National Pharmaceutical Assistance Policy (PNAF). Taking into consideration that some goals of PNM are the access that propose fair availability and accessibility to medicines; its quality, safety and effectiveness and its rational use, the brazilian government had the initiative of implementing a strategy on public policies: the drugs fractionation. This study intends to analyze the mentioned strategy implement on its course from 2005 to 2009, and it has the following objectives: 1) Compare it to the proposes suggested by the PNM and PNAF; 2) Promote an overview of the development and actions currently realized; 3) To reflect together with the actions developed in Brazil in recent years to promote access and rational use of medicines. We searched the type documentary analysis and literature through a systematic study developed out of publications, documents and legislation in the field of drugs, referring to policies and regulatory aspects of the pharmaceutical sector in Brazil. Fractionation of drugs was discussed by building normative reference from raising chronological perspective view of the Brazilian government. Through data based on registers publications of fractionated medicines, some observations concerning development of regulatory actions have been made. Changes in the drug chain, considering the Brazilian reality show that any deployment of new forms of manufacturing, selling, prescribing, dispensing and using drugs, not simply to become effective regulatory actions applied alone. Membership and development of this strategy by all stakeholders requires time, actions comprehensive, objective and coherent with the guidelines of the policies guiding.

O setor farmacêutico brasileiro tem passado por importantes transformações nos últimos anos, entre elas a aprovação da Política Nacional de Medicamentos (PNM), a criação da Agência Nacional de Vigilância Sanitária (Anvisa), a publicação da Lei de Genéricos e a aprovação da Política Nacional de Assistência Farmacêutica (PNAF). Considerando que alguns dos objetivos da PNM são o acesso que propõe disponibilidade equitativa e acessibilidade; a qualidade, segurança e eficácia e o uso racional relativos à medicamentos, é que houve a iniciativa do governo brasileiro em implementar uma estratégia na área de políticas de saúde, o fracionamento de medicamentos. Este estudo procura analisar a implementação desta estratégia e o seu decurso de 2005 a 2009, tendo como objetivos: 1) compará-lo com as propostas preconizadas pela PNM e PNAF; 2) promover um panorama do desenvolvimento e das ações atualmente realizadas; 3) refletir em conjunto com as ações desenvolvidas no Brasil nos últimos anos para a promoção do acesso e uso racional de medicamentos. Foi realizada uma pesquisa do tipo análise documental e bibliográfica por meio de um estudo sistematizado desenvolvido a partir de material bibliográfico, documentos e legislações na área de medicamentos, fazendo alusão às políticas e aos aspectos regulatórios do setor farmacêutico no Brasil. O fracionamento de medicamentos foi discutido por meio da construção normativa a partir de referencial cronológico suscitando perspectivas da visão do governo brasileiro. Com dados dos registros de medicamentos fracionáveis, foram traçadas algumas observações acerca do planejamento e desenvolvimento das ações regulatórias. Alterações na cadeia do medicamento, considerando a realidade brasileira, demonstram que qualquer implantação de novas formas de fabricar, comercializar, prescrever, dispensar e utilizar medicamentos, não se efetivará simplesmente com atos regulamentares aplicados isoladamente. A adesão e desenvolvimento desta estratégia por parte de todos os atores envolvidos requer tempo, ações abrangentes, objetivas e coesas com as diretrizes das políticas norteadoras. / The Brazilian pharmaceutical industry has been changing considerably throughout last years. It could be mentioned, as the most important changes ocurred, the approval of National Drugs Policy (PNM), the creation of The National Agency of Health Surveillance (Anvisa), the publishing of Generic Drugs Law and the approval of National Pharmaceutical Assistance Policy (PNAF). Taking into consideration that some goals of PNM are the access that propose fair availability and accessibility to medicines; its quality, safety and effectiveness and its rational use, the brazilian government had the initiative of implementing a strategy on public policies: the drugs fractionation. This study intends to analyze the mentioned strategy implement on its course from 2005 to 2009, and it has the following objectives: 1) Compare it to the proposes suggested by the PNM and PNAF; 2) Promote an overview of the development and actions currently realized; 3) To reflect together with the actions developed in Brazil in recent years to promote access and rational use of medicines. We searched the type documentary analysis and literature through a systematic study developed out of publications, documents and legislation in the field of drugs, referring to policies and regulatory aspects of the pharmaceutical sector in Brazil. Fractionation of drugs was discussed by building normative reference from raising chronological perspective view of the Brazilian government. Through data based on registers publications of fractionated medicines, some observations concerning development of regulatory actions have been made. Changes in the drug chain, considering the Brazilian reality show that any deployment of new forms of manufacturing, selling, prescribing, dispensing and using drugs, not simply to become effective regulatory actions applied alone. Membership and development of this strategy by all stakeholders requires time, actions comprehensive, objective and coherent with the guidelines of the policies guiding.

This Thesis examines the benefits and usefulness of a National Drug Policy (NDP) for the developing of the Health Care System in Kuwait. The NDP is one of the most important structures of the Health System which can lead to improved health services by establishing guidelines, proposals and directives to organize, structure and regulate health legislation; it is of help to ensure the availability of quality, safety and efficacy in using medicines and it can reduce the irrational use of medicines. The NDP is a frame work between the government, schools and universities, media, health professionals, pharmaceutical industries and companies and public. It is cooperation between the public and private sectors to achieve the goal of access to good quality medicines for all. However there are many key factors which need to be examined before the National Drug Policy is introduced and these are considered the baseline for establishing a good policy, and includes; selection of essential drugs, affordability of drugs, drug financing, supply management, drug regulation, rational use of drugs, drugs registration, purchasing of drugs, health research and human resource development. During this research study from 2012 – 2015 several visits to the public and private health areas, were undertaken. At this time there were discussions with 121 health professionals and data was collected and this indicated that in Kuwait there are no such policies. This is despite the availability of financial means, specialized human resources and the existence of the ministerial decisions and regulations governing the health sector in both public and private, whether hospitals, health centers, pharmacies and health departments. In addition it is suggested that the process of a good NDP should be built around 3 main components which includes: 1.Development, 2. Implementation and 3. Monitoring and Evaluation. Therefore the establishing of a NDP without implementation and monitoring is not enough and does not achieve the desired results. The aim of this Thesis is to establish a NDP in the State of Kuwait. This policy is necessary for the State of Kuwait to ensure development an improvement of the Health Care System and ensure better health for population.

As doenças inflamatórias intestinais (DII) - doença de Crohn e retocolite ulcerativa, são condições crônicas que, na maioria dos casos, exigem controle com terapia medicamentosa. A atenção farmacêutica (AF), definida como a provisão responsável do tratamento farmacológico, com o propósito de alcançar resultados concretos que melhorem a qualidade de vida do paciente, constitui nova forma de cuidado ao paciente, que necessita ser mais extensivamente avaliada. Este estudo teve o objetivo de avaliar a contribuição da atenção farmacêutica ao tratamento clínico de pacientes com DII em acompanhamento ambulatorial em hospital terciário. Ao longo de um ano, foi avaliado um grupo que recebeu a atenção farmacêutica (GAF; N=18) e um grupo controle (GC; N=17) não submetido aos procedimentos da AF. Os resultados da contribuição da AF foram avaliados pela comparação de diferentes variáveis entre os grupos, que foram obtidas na primeira entrevista - T(0), aos seis - T(6) e 12 - T(12) meses do estudo. Quanto aos aspectos clínicos, houve redução significativa dos índices de atividade clínica de T(6) para T(12) no GAF (mediana; variação: 2,20; 0,99 3,77 versus 1,90; 0,99 3,77; p=0,02), o que não ocorreu no GC (1,69; 0,99 3,77 versus 1,69; 0,99 3,48). No GAF, houve aumento significativo do percentual de pacientes mais aderentes ao tratamento medicamentoso (27,8% versus 72,2%; p<0,05), quando da avaliação por meio do teste de Morisky, mas não foram observadas diferenças (72,2% versus 88,9%) na adesão avaliada pelo cotejo entre medicamentos utilizados e prescrições registradas. Em ambas as formas de avaliação da adesão, tanto pelo teste de Morisky (41,2% versus 41,2%), quanto pelo confronto das medicações utilizadas e prescrições registradas (88,2% versus 82,4%), não foram observadas alterações no GC. Houve aumento significativo dos índices de conhecimento do paciente sobre o tratamento no GAF entre T(0) e T(12) (mediana; variação: 80%; 40% 100% versus 100%; 100% 100%; p0,0001), o que não ocorreu no GC (80%; 0 100% versus 80%; 60% 100%). No que se refere à qualidade de vida, avaliada pelo instrumento SF36, houve diferenças estatisticamente significativas nos dois grupos apenas no domínio de saúde mental. No GAF, houve elevação dos escores deste domínio entre T(0) e T(12) (54,0 versus 66,0; p=0,04), o que, também ocorreu no GC (60,0 versus 68,0; p=0,01). Porém, no GAF, esta mudança ocorreu mais precocemente, de T(0) para T(6) (54,0 versus 66,0; p<0,01). A AF possibilitou a identificação, em média, de 3,8 problemas relacionados ao medicamento por paciente, que em sua maioria foram resolvidos, com intervenções predominantemente focadas em orientações aos pacientes. Os pacientes do GAF, ao término do estudo, apresentaram alto grau de satisfação com a AF. Os resultados obtidos permitem concluir que a introdução de um programa de atenção farmacêutica a pacientes ambulatoriais com DII seguidos em hospital terciário trouxe contribuição positiva, proporcionando benefícios mensuráveis aos pacientes. / Inflammatory bowel diseases (IBD) Crohns disease and ulcerative colitis are chronic conditions which are usually controlled with drug therapy. Pharmaceutical care (PC), defined as the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve patients quality of life, is a new patient care modality, which needs to be more extensively evaluated. This study aimed at assessing the contribution of pharmaceutical care to the clinical treatment of outpatients with IBD assisted at a reference hospital. During one year, a group receiving pharmaceutical care (PCG; N=18) and a control group (CG; N=17), which did not undergo PC procedures, were evaluated. Results of PC contribution were assessed by comparing the two groups regarding different variables obtained in the first interview at - T(0), at six - T(6) and 12 - T(12) months of study. Regarding the clinical aspects, there was a significant decrease of clinical activity indexes from T(6) to T(12) in the PCG (median; range: 2.20; 0.99 3.77 versus 1.90; 0.99 3.77; p=0.22), but not in the CG (1.69; 0.99 3.77 versus 1.69; 0.99 3.48). In the PCG, there was a significant increase in the percentage of patients who were more compliant to drug treatment (27.8 % versus 72.2 %; p<0.05) as assessed using the Morisky scale; however, no differences in compliance rates were observed (72.2 % versus 88.9 %) by comparing drugs taken with registered prescriptions. In the CG, no differences were observed in none of the compliance assessment methods, neither by the Morisky scale (41.2% versus 41.2%), nor by comparing drugs taken with registered prescriptions (88.2% versus 81.2%). There was a significant increase in the values of an index for patients knowledge about the treatment in the PCG between T(0) and T(12) (median; range: 80%; 40 100 versus 100%; 100 100; p0,0001), but not in the CG (80%; 0 100 versus 80%; 60 100). With respect to quality of life, assessed by the SF36 scale, there were statistically significant differences in both groups only in the mental health domain. There was an increase in scores for this domain between T(0) and T(12) in both PCG (54.0 versus 66.0; p=0,04), and CG (60.0 versus 68.0; p=0,01). However, PCG had this increasing scores earlier, between T(0) and T(12) (54.0 versus 74.0; p<0,01). PC enabled the identification of a number of drug-related problems per patient (mean = 3.8), which were mostly solved by interventions predominantly focused on patient orientation. At the end of the study, patients in the PC group showed a high degree of satisfaction with the intervention. The achieved results allow concluding that the implementation of a pharmaceutical care program to outpatients with IBD followed at a tertiary hospital gave a positive contribution, providing measurable benefits to patients.

As doenças inflamatórias intestinais (DII) - doença de Crohn e retocolite ulcerativa, são condições crônicas que, na maioria dos casos, exigem controle com terapia medicamentosa. A atenção farmacêutica (AF), definida como a provisão responsável do tratamento farmacológico, com o propósito de alcançar resultados concretos que melhorem a qualidade de vida do paciente, constitui nova forma de cuidado ao paciente, que necessita ser mais extensivamente avaliada. Este estudo teve o objetivo de avaliar a contribuição da atenção farmacêutica ao tratamento clínico de pacientes com DII em acompanhamento ambulatorial em hospital terciário. Ao longo de um ano, foi avaliado um grupo que recebeu a atenção farmacêutica (GAF; N=18) e um grupo controle (GC; N=17) não submetido aos procedimentos da AF. Os resultados da contribuição da AF foram avaliados pela comparação de diferentes variáveis entre os grupos, que foram obtidas na primeira entrevista - T(0), aos seis - T(6) e 12 - T(12) meses do estudo. Quanto aos aspectos clínicos, houve redução significativa dos índices de atividade clínica de T(6) para T(12) no GAF (mediana; variação: 2,20; 0,99 3,77 versus 1,90; 0,99 3,77; p=0,02), o que não ocorreu no GC (1,69; 0,99 3,77 versus 1,69; 0,99 3,48). No GAF, houve aumento significativo do percentual de pacientes mais aderentes ao tratamento medicamentoso (27,8% versus 72,2%; p<0,05), quando da avaliação por meio do teste de Morisky, mas não foram observadas diferenças (72,2% versus 88,9%) na adesão avaliada pelo cotejo entre medicamentos utilizados e prescrições registradas. Em ambas as formas de avaliação da adesão, tanto pelo teste de Morisky (41,2% versus 41,2%), quanto pelo confronto das medicações utilizadas e prescrições registradas (88,2% versus 82,4%), não foram observadas alterações no GC. Houve aumento significativo dos índices de conhecimento do paciente sobre o tratamento no GAF entre T(0) e T(12) (mediana; variação: 80%; 40% 100% versus 100%; 100% 100%; p0,0001), o que não ocorreu no GC (80%; 0 100% versus 80%; 60% 100%). No que se refere à qualidade de vida, avaliada pelo instrumento SF36, houve diferenças estatisticamente significativas nos dois grupos apenas no domínio de saúde mental. No GAF, houve elevação dos escores deste domínio entre T(0) e T(12) (54,0 versus 66,0; p=0,04), o que, também ocorreu no GC (60,0 versus 68,0; p=0,01). Porém, no GAF, esta mudança ocorreu mais precocemente, de T(0) para T(6) (54,0 versus 66,0; p<0,01). A AF possibilitou a identificação, em média, de 3,8 problemas relacionados ao medicamento por paciente, que em sua maioria foram resolvidos, com intervenções predominantemente focadas em orientações aos pacientes. Os pacientes do GAF, ao término do estudo, apresentaram alto grau de satisfação com a AF. Os resultados obtidos permitem concluir que a introdução de um programa de atenção farmacêutica a pacientes ambulatoriais com DII seguidos em hospital terciário trouxe contribuição positiva, proporcionando benefícios mensuráveis aos pacientes. / Inflammatory bowel diseases (IBD) Crohns disease and ulcerative colitis are chronic conditions which are usually controlled with drug therapy. Pharmaceutical care (PC), defined as the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve patients quality of life, is a new patient care modality, which needs to be more extensively evaluated. This study aimed at assessing the contribution of pharmaceutical care to the clinical treatment of outpatients with IBD assisted at a reference hospital. During one year, a group receiving pharmaceutical care (PCG; N=18) and a control group (CG; N=17), which did not undergo PC procedures, were evaluated. Results of PC contribution were assessed by comparing the two groups regarding different variables obtained in the first interview at - T(0), at six - T(6) and 12 - T(12) months of study. Regarding the clinical aspects, there was a significant decrease of clinical activity indexes from T(6) to T(12) in the PCG (median; range: 2.20; 0.99 3.77 versus 1.90; 0.99 3.77; p=0.22), but not in the CG (1.69; 0.99 3.77 versus 1.69; 0.99 3.48). In the PCG, there was a significant increase in the percentage of patients who were more compliant to drug treatment (27.8 % versus 72.2 %; p<0.05) as assessed using the Morisky scale; however, no differences in compliance rates were observed (72.2 % versus 88.9 %) by comparing drugs taken with registered prescriptions. In the CG, no differences were observed in none of the compliance assessment methods, neither by the Morisky scale (41.2% versus 41.2%), nor by comparing drugs taken with registered prescriptions (88.2% versus 81.2%). There was a significant increase in the values of an index for patients knowledge about the treatment in the PCG between T(0) and T(12) (median; range: 80%; 40 100 versus 100%; 100 100; p0,0001), but not in the CG (80%; 0 100 versus 80%; 60 100). With respect to quality of life, assessed by the SF36 scale, there were statistically significant differences in both groups only in the mental health domain. There was an increase in scores for this domain between T(0) and T(12) in both PCG (54.0 versus 66.0; p=0,04), and CG (60.0 versus 68.0; p=0,01). However, PCG had this increasing scores earlier, between T(0) and T(12) (54.0 versus 74.0; p<0,01). PC enabled the identification of a number of drug-related problems per patient (mean = 3.8), which were mostly solved by interventions predominantly focused on patient orientation. At the end of the study, patients in the PC group showed a high degree of satisfaction with the intervention. The achieved results allow concluding that the implementation of a pharmaceutical care program to outpatients with IBD followed at a tertiary hospital gave a positive contribution, providing measurable benefits to patients.