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1.
Clinicoecon Outcomes Res ; 14: 587-599, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36105845

RESUMO

Purpose: To assess the direct and indirect costs associated with adverse drug reactions (ADRs) in patients receiving treatment regimens for human immunodeficiency virus (HIV) infection and tuberculosis (TB) in selected Thai hospitals. Patients and Methods: This was a retrospective study conducted between October 2014 and September 2019 at three public hospitals in Thailand. Data were obtained from a medical database and spontaneous ADR reporting system of each study site. The out-of-pocket health payments and indirect costs were determined via interviewing. All costs were updated to 2021. Results: A total of 432 eligible patients who experienced ADRs due to HIV and TB treatment, and 93 patients were interviewed to determine direct non-medical and indirect costs. The average direct medical cost for ADR was USD 5.65 for mild cases, USD 156.54 for moderate cases, and USD 1,242.45 for severe cases. For direct non-medical costs, the average cost per episode was USD 27.29 in mild ADR, USD 70.86 in moderate ADR and USD 270.66 in severe ADR. The indirect cost incurred in each mild, moderate and severe ADR was USD 41.86, USD 89.34, and USD 552.60, respectively. The Stevens-Johnson syndrome (SJS) had the highest management costs. Conclusion: ADRs associated with anti-tuberculosis drugs and antiretroviral drugs seem to have a substantial economic impact from a societal perspective. These findings would be useful for increasing awareness and encouraging early avoidance of ADRs.

2.
Phytomedicine ; 101: 154115, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-35523116

RESUMO

BACKGROUND: Osteopenia refers to bone density that is not normal but also not as low as that noted in osteoporosis. Osteopenia leads to osteoporosis and increases the risk of fractures. Current research is focused on agents that will prevent or slow the progression of bone loss. On the basis of published evidence, Cissus quadrangularis (CQ) might potentially provide a novel natural treatment for osteopenia. PURPOSE: To determine the effect of 24 weeks of consecutive treatment with CQ on delaying bone loss and safety in postmenopausal women (PMW) with osteopenia. METHODS: This study is a randomized, placebo-controlled trial. Here, 134 enrolled PMW with osteopenia (> 40 years and having no period for 1-10 years) received CQ at 1.2 (CQ1.2) or 1.6 g/day (CQ1.6) or placebo. The %change in bone mineral density (BMD) at the lumbar spine (L1-L4), femoral neck, and total hip served as the primary outcome. The %change in bone turnover markers (BTMs), including C-terminal telopeptide of type 1 collagen (CTX) and procollagen type 1 amino-terminal propeptide (P1NP), was the secondary outcome. These outcomes were compared between the CQ vs. placebo group at weeks 12 and 24. The least significant change (LSC) was used to monitor clinical changes. The adverse events (AE) were monitored. RESULTS: A total of 108 participants completed this study. The %BMD changes in the CQ-treated groups did not differ at any site after 24 weeks compared to the placebo. Statistically significant differences were detected in CQ1.6 at the lumbar spine (0.011 ± 0.025 g/cm2, p = 0.008) and CQ1.2 at the femoral neck (-0.015 ± 0.036 g/cm2, p = 0.024) compared to baseline, but these changes did not exceed the LSC. Reduced bone remodeling activity was detected in both CQ-treated groups. Compared to the placebo, the %P1NP change was significantly reduced in CQ1.6 (-2.46 ± 26.05%; p < 0.01) at week 12 and in CQ1.2 (-3.36 ± 29.47%; p < 0.01) and CQ1.6 (-9.95 ± 22.22%; p < 0.01) at week 24. These results correlated with the within-group comparison, which showed a continuously significant increase in both BTMs in the placebo group. However, a stable CTX and a significant reduction in P1NP (p < 0.05) were detected in both CQ-treated groups. This reduction exceeded the LSC of P1NP. The incidence of adverse events did not differ among the three groups. CONCLUSION: This is the first clinical report that showed a promising effect on delaying bone loss of orally administration of CQ for 24 weeks, as indicated by a slower bone remodeling process via a reduction in BTMs. However, no change in BMD was observed.


Assuntos
Conservadores da Densidade Óssea , Doenças Ósseas Metabólicas , Cissus , Osteoporose Pós-Menopausa , Osteoporose , Biomarcadores , Densidade Óssea , Conservadores da Densidade Óssea/efeitos adversos , Doenças Ósseas Metabólicas/tratamento farmacológico , Colágeno Tipo I , Método Duplo-Cego , Feminino , Humanos , Osteoporose/tratamento farmacológico , Osteoporose Pós-Menopausa/tratamento farmacológico , Pós-Menopausa
3.
Infect Drug Resist ; 15: 439-453, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35177911

RESUMO

PURPOSE: To evaluate the optimal dosing regimens of meropenem against extended-spectrum beta-lactamase-producing Escherichia coli (ESBL E. coli) in critically ill patients with varying degrees of renal function using Monte Carlo simulation (MCS). METHODS: The MCS was performed using the minimum inhibitory concentration (MIC) data from Right Laboratory and Health Screen in Naypyitaw, Myanmar, as well as reported meropenem pharmacokinetic parameters in the target population and the pharmacokinetic-pharmacodynamic index. For each dosing regimen, 10,000 virtual patients were generated to assess the probability of target attainment (PTA) and the cumulative fraction of response (CFR). The most effective dosage regimens were determined using PTA and a CFR of 90%. RESULTS: ESBL E. coli made up 93 of the 396 clinical E. coli isolates, and they are all multidrug-resistant, with resistance to at least five antibiotic classes. The MIC50 and MIC90 were determined to be 0.25 µg/mL. The PTA was affected by five factors: creatinine clearance (CLcr), vasopressor usage, MIC, infusion time, and dosage fractionation. In patients who did not receive vasopressors, the current regimens (US-FDA and EMA) were ineffective in all renal function for MIC >0.25µg/mL. In the subset group of CLcr >80 mL/min for MIC 2µg/mL, the maximum total daily dose of 6g/day (2g q 8hr; 3hr infusion) was still ineffective, but 4g/day (1g q 6hr; 3hr infusion) achieved 98.96% PTA. Almost majority of the simulated regimens produced >90% PTA in vasopressor-dependent patients with all levels of renal function, resulting in a decreased total daily dose requirement. CONCLUSION: For high MIC (>1µg/mL) patients who do not use vasopressors and have a CLcr >80 mL/min, a combination of dosage fractionation and the extended infusion was considered as an effective technique to maximize target attainment. Neither prolonged infusion nor dosage fractionation should be explored in patients using vasopressors.

4.
Antibiotics (Basel) ; 10(5)2021 May 17.
Artigo em Inglês | MEDLINE | ID: mdl-34067716

RESUMO

Our aims are to assess various colistin dosing regimens against Pseudomonas aeruginosa (P. aeruginosa) infection in critically ill patients and to propose an appropriate regimen based on microbiological data. A Monte Carlo simulation was performed using the published colistin's pharmacokinetic parameters of critically ill patients, the published pharmacodynamic target from a mouse thigh infection model, and the minimum inhibitory concentration (MIC) results from a Vietnamese hospital. The probability of target attainment (PTA) of 80% and cumulative fraction of response (CFR) of 90% were used to evaluate the efficacy of each regimen. Of 121 P. aeruginosa laboratory datasets, the carbapenem-resistant P. aeruginosa (CRPA) and the colistin-resistant P. aeruginosa rates were 29.8% and 0.8%, respectively. MIC50,90 were both 0.5 mg/L. The simulated results showed that at MIC of 2 mg/L, most regimens could not reach the PTA target, particularly in patients with normal renal function (Creatinine clearance (CrCl) ≥ 80 mL/min). At MIC of 0.5 mg/L and 1 mg/L, current recommendations still worked well. On the basis of these results, aside from lung infection, our study recommends three regimens against P. aeruginosa infection at MIC of 0.5 mg/L, 1 mg/L, and 2 mg/L. In conclusion, higher total daily doses and fractionated colistin dosing regimens could be the strategy for difficult-to-acquire PTA cases, while a less aggressive dose might be appropriate for empirical treatment in settings with low MIC50/90.

5.
Pharmacogenomics ; 22(8): 465-472, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33910375

RESUMO

Aim: A case-control study was conducted in Filipino patients to determine the association between HLA alleles and carbamazepine-induced Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN). Materials & methods: A retrospective review of medical records and data collection were performed. A total of 10 carbamazepine-induced SJS/TEN cases and 40 tolerant controls were recruited. Genomic DNA extracted from saliva samples was genotyped. Statistical analysis was done. Results: The HLA-B75 serotype (p = 0.003; odds ratio [OR] = 13.8; 95% CI = 2.5-76.8), HLA-B*15:21 (p = 0.041; OR = 4.7; 95% CI = 1.1-20.8) and HLA-A*24:07 (p = 0.032; OR = 6; 95% CI = 1.2-30.7) were significantly associated with carbamazepine-induced SJS/TEN. Conclusion: The HLA-B75 serotype, HLA-B*15:21 or HLA-A*24:07 may be used for pharmacogenetic screening prior to prescribing carbamazepine in Filipinos.


Assuntos
/genética , Carbamazepina/efeitos adversos , Antígenos HLA-A/genética , Polimorfismo Genético/genética , Síndrome de Stevens-Johnson/genética , Adolescente , Adulto , Alelos , Biomarcadores/metabolismo , Estudos de Casos e Controles , DNA/genética , Feminino , Predisposição Genética para Doença/genética , Genótipo , Antígenos HLA-B/genética , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Síndrome de Stevens-Johnson/etiologia , Adulto Jovem
6.
Pharmacogenet Genomics ; 30(4): 73-80, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32187156

RESUMO

BACKGROUND AND OBJECTIVES: Pharmacogenomics (PGx) is the use of human genomic information to avoid toxicity and optimize efficacy of drug therapy in an individual. Hospital pharmacists are the key persons to facilitate the incorporation of PGx into clinical practice. PGx is relatively new to Thai hospital pharmacists. Therefore, this study aimed to evaluate the knowledge, attitude, and practice of Thai hospital pharmacists towards PGx implementation. MATERIALS AND METHODS: We conducted a cross-sectional questionnaire-based survey among 600 hospital pharmacists in 21 hospitals across Thailand. The questionnaire consisted of 35 questions using comment boxes, Likert scales, and multiple choice answers. RESULTS: The response rate was 20.5% (n = 123). Nearly half of the hospital pharmacists (46.3%) had low PGx knowledge score (<5 points), particularly for applied PGx knowledge in clinical situations. Concerns regarding PGx reimbursement, privacy issues, and discrimination were mentioned in this survey. However, most hospital pharmacists had positive attitude towards PGx service. Only 7% of hospital pharmacists had recommended or interpreted PGx tests in the past year. National PGx guidelines and government policies were considered the important factors for PGx implementation. Moreover, the most preferred learning format for PGx education was professional academic conferences. CONCLUSION: Hospital pharmacists in Thailand had positive attitude towards PGx, despite limited experience and practice of PGx. PGx education to support an application of PGx knowledge in clinical situations is required. National PGx guidelines and government policies may need to be developed to address the concerns for reimbursement, privacy, and discrimination to ensure successful PGx implementation.


Assuntos
Conhecimentos, Atitudes e Prática em Saúde , Farmacêuticos/normas , Farmacogenética/tendências , Adulto , Feminino , Hospitais/normas , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários , Tailândia/epidemiologia
7.
Contemp Clin Trials Commun ; 17: 100538, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32072072

RESUMO

BACKGROUND: Scientific support for Thai traditional medicine (TTM) practice is warranted for reintroduction into modern healthcare systems. A promising TTM practice for treatment of pressure ulcers was selected to conduct a clinical trial. This study aimed to evaluate the efficacy of the TTM practice for the treatment of pressure ulcers using honey or a Thai Herbal Oil preparation (THO) based on the TTM wound diagnosis comparing with the standard practice. METHODS: The study design was an open-label randomized controlled trial. Sixty-six participants, with pressure ulcers at least stage II-IV or unstageable, were allocated to two groups via minimization. A TTM practice group received honey or THO depending on the TTM diagnosis via the Thai Traditional Medicine Pressure Ulcer Assessment Tool (TTM-PUAT). A standard practice group received advanced dressings, including hydrogel, alginate, silver-impregnated, or hydrocolloid dressings. The primary outcome was the Pressure Ulcer Scale for Healing (PUSH). RESULTS: Both TTM practice and standard practice showed a significant reduction in PUSH scores after treatments. However, there was no significant difference in PUSH score reduction between the groups. The mean PUSH score reduction over the 6-week period was 2.58 ± 3.38 (95% CI 1.34-3.82) in the TTM practice group and 3.24 ± 3.49 (95% CI 1.91-4.57) in the standard practice group (p = 0.284). The TTM practice and standard practice accelerated pressure ulcer healing without statistically significant difference between the practices, during 6 weeks in a home-based care setting. This finding supported the TTM practice as an alternative treatment for pressure ulcer.

8.
Pharmacogenomics J ; 20(3): 533-541, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-31896765

RESUMO

A case-control study was conducted to investigate the association of HLA-A alleles, HLA-B alleles including HLA-B*15:02 and HLA-B75 serotype with carbamazepine-induced SJS/TEN in Filipino patients. A retrospective review of medical records was performed. Pertinent clinical data were collected. Eight (8) carbamazepine-induced SJS/TEN cases and 32 tolerant controls were recruited. Genomic DNA was extracted from the saliva samples and genotyping was performed by employing allele-specific polymerase chain reaction. Data were analyzed using the Fisher's exact test, Mann-Whitney U test, univariate logistic regression, and multivariate logistic regression. Single allele association analysis was done. The strength of association was expressed as odds ratio with 95% confidence interval. Positive predictive value, negative predictive value, sensitivity, and specificity were computed. Of all the alleles tested, the HLA-B75 serotype (p = 0.007, OR = 23.25, 95% CI = 2.33-232.21) and HLA-B*15:21 (p = 0.026, OR = 7.53, 95% CI = 1.27-44.79) were significantly associated with carbamazepine-induced SJS/TEN. The HLA-B75 serotype or HLA-B*15:21 allele may be used as a genetic risk assessment prior to prescription for prevention of carbamazepine-induced SJS/TEN in Filipino patients.


Assuntos
Anticonvulsivantes/efeitos adversos , Carbamazepina/efeitos adversos , Antígenos HLA-B/genética , Sorogrupo , Síndrome de Stevens-Johnson/genética , Adulto , Alelos , Estudos de Casos e Controles , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Filipinas/epidemiologia , Síndrome de Stevens-Johnson/epidemiologia , Adulto Jovem
9.
Public Health Genomics ; 22(3-4): 132-139, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31587001

RESUMO

Pharmacogenomics (PGx) is increasingly being recognized as a potential tool for improving the efficacy and safety of drug therapy. Therefore, several efforts have been undertaken globally to facilitate the implementation process of PGx into routine clinical practice. Part of these efforts include the formation of PGx working groups working on PGx research, synthesis, and dissemination of PGx data and creation of PGx implementation strategies. In Asia, the Southeast Asian Pharmacogenomics Research Network (SEAPharm) is established to enable and strengthen PGx research among the various PGx communities within but not limited to countries in SEA; with the ultimate goal to support PGx implementation in the region. From the perspective of SEAPharm member countries, there are several key elements essential for PGx implementation at the national level. They include pharmacovigilance database, PGx research, health economics research, dedicated laboratory to support PGx testing for both research and clinical use, structured PGx education, and supportive national health policy. The status of these essential elements is presented here to provide a broad picture of the readiness for PGx implementation among the SEAPharm member countries, and to strengthen the PGx research network and practice in this region.


Assuntos
Relações Interprofissionais , Farmacogenética/estatística & dados numéricos , Ásia , Ásia Sudeste , Doença Hepática Induzida por Substâncias e Drogas/prevenção & controle , Difusão de Inovações , Erupção por Droga/prevenção & controle , Humanos , Farmacogenética/economia
10.
Artigo em Inglês | MEDLINE | ID: mdl-31405868

RESUMO

Sitafloxacin showed potent activity against various respiratory pathogens. Blood and bronchoalveolar lavage (BAL) fluid samples were obtained from 12 subjects after a single oral dose of sitafloxacin 200 mg. The mean ± SD (median) maximum ratio of epithelial lining fluid (ELF) to unbound plasma concentration was 1.02 ± 0.58 (1.33). The penetration ratios based on the mean and median area under the curve from 0 to 8 h (AUC0-8) were 0.85 and 0.79 µg · h/ml, respectively. Sitafloxacin penetrates well into ELF in critically ill Thai patients with pneumonia. (This study has been registered in the Thai Clinical Trials Registry [TCTR] under registration no. TCTR20170222001.).


Assuntos
Antibacterianos/farmacocinética , Antibacterianos/uso terapêutico , Fluoroquinolonas/farmacocinética , Fluoroquinolonas/uso terapêutico , Macrófagos Alveolares/efeitos dos fármacos , Pneumonia/tratamento farmacológico , Mucosa Respiratória/efeitos dos fármacos , Adulto , Idoso , Lavagem Broncoalveolar/métodos , Líquido da Lavagem Broncoalveolar , Estado Terminal , Feminino , Humanos , Pulmão/efeitos dos fármacos , Pulmão/microbiologia , Macrófagos Alveolares/metabolismo , Masculino , Pessoa de Meia-Idade , Pneumonia/metabolismo , Mucosa Respiratória/microbiologia , Tailândia
11.
BMJ Case Rep ; 20182018 Jul 17.
Artigo em Inglês | MEDLINE | ID: mdl-30018035

RESUMO

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are two related mucocutaneous disorders with different severities. Although the incidence is low, SJS and TEN are life-threatening and predominantly drug-induced conditions. There is a strong relationship between the HLA-B*1502 allele and carbamazepine-induced SJS and TEN in different Southeast Asian populations. Here, we report a case of Filipino with SJS/TEN overlap probably induced by carbamazepine. The condition was treated with hydrocortisone followed by prednisone. The HLA-B*1502 allele was not found in this case. The patient tested positive for the HLA-B75 serotype, suggesting that carbamazepine-induced SJS/TEN may be serotype specific. Establishing the genotype before initiation of the drug may be advantageous for some patients and will aid physicians in determining the optimal drug therapy. Prevention of adverse drug reactions (ADR) may be done if pharmacists and other healthcare professionals work as a multidisciplinary ADR team to ensure that safe medication practices are realised.


Assuntos
Antimaníacos/efeitos adversos , Carbamazepina/efeitos adversos , Antígenos HLA-B/sangue , Transtornos Mentais/tratamento farmacológico , Síndrome de Stevens-Johnson/etiologia , Adulto , Humanos , Masculino , Síndrome de Stevens-Johnson/genética
12.
Drug Saf ; 39(12): 1239-1250, 2016 12.
Artigo em Inglês | MEDLINE | ID: mdl-27743333

RESUMO

INTRODUCTION: The Bhutan National Pharmacovigilance Centre (NPC) became an official member of the WHO Programme for International Drug Monitoring in December 2014; however, the number of adverse drug reactions (ADRs) reported is very low (50 reports per 773,722 inhabitants over 10 years). Surveys of healthcare professionals (HCPs) in similar countries have indicated that adequate knowledge of both ADRs and ADR reporting is likely to increase the number of ADR reports submitted. OBJECTIVE: The aim of this study was to investigate the level of knowledge of both ADRs and ADR reporting among HCPs, including traditional medicine practitioners. METHODS: A cross-sectional survey was conducted, using a validated self-administered questionnaire. The questionnaires were distributed to 670 HCPs, including clinical doctors, nurses, pharmacists and traditional medicine practitioners from four referral hospitals. The survey consisted of 12 questions pertaining to ADRs and 10 questions pertaining to knowledge of ADR reporting. The collected response was then analysed descriptively and results presented as mean ± standard deviation (SD) using SPSS version 20. RESULTS: The overall response rate was 434 (65 %) questionnaires, with HCPs consisting of clinical doctors (94, 22 %), nurses (257, 59 %), pharmacists (52, 12 %) and traditional medicine practitioners (31, 7 %). The overall mean ± SD score with regard to the level of knowledge of ADRs was 6.52 ± 2.81 out of a maximum score of 12, among which clinical doctors scored 7.48 ± 2.95, nurses 6.15 ± 2.47, pharmacists 8.15 ± 2.49 and traditional medicine practitioners 4.13 ± 3.18. The mean ± SD score with regard to the level of knowledge of ADR reporting among HCPs was 3.94 ± 1.89 out of a maximum score of 10, among which clinical doctors scored 3.93 ± 1.81, nurses 3.75 ± 1.74, pharmacists 5.00 ± 1.81 and traditional medicine practitioners 4.00 ± 1.77. CONCLUSION: Clinical doctors and pharmacists have better knowledge of ADRs than nurses and traditional medicine practitioners, while knowledge of ADR reporting was low for all HCPs surveyed.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Conhecimentos, Atitudes e Prática em Saúde , Pessoal de Saúde , Adulto , Butão , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Farmacovigilância , Inquéritos e Questionários , Adulto Jovem
13.
J Hum Genet ; 61(2): 119-27, 2016 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-26423926

RESUMO

The objectives of this study are to investigate allele frequencies of drug absorption, distribution, metabolism and elimination (ADME)-related genes in the Thai population and to compare these genes to HapMap populations including Caucasians (CEU), Africans (YRI) and Asians (CHB/JPT). Genetic variations of drug ADME-related genes in 190 Thais were investigated using drug metabolizing enzymes and transporters (DMET) plus genotyping system. We examined 1936 single nucleotide polymorphisms (SNPs) of 225 genes that have documented functional and clinical significances in phase I and phase II drug metabolism enzymes, drug transporters and other genes involved in ADME processes. Distributions of genotyping data from Thai were compared with other HapMap populations including Caucasian, African and Asian populations. The analysis demonstrated 43 SNPs with statistical significance comparing among five populations. However, only 26 SNPs showed statistical significance in pair-wise comparisons between Thai versus CEU and Thai versus CHB/JPT. These 26 SNPs belong to 13 groups of drug ADME-related genes which are CYP2A6, CYP3A5, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, VKORC1, COMT, NAT2, TPMT, UGT1A1 and SLCO1B1. These genes demonstrated clinical significances as previously observed in many studies. The results could explain clinical variability in pharmacokinetics and pharmacodynamics of drugs in Thais based on genetic variations in drug ADME-related gene emphasized in this article.


Assuntos
Variantes Farmacogenômicos , Polimorfismo de Nucleotídeo Único , /genética , Frequência do Gene , Projeto HapMap , Humanos , Inativação Metabólica/genética , Proteínas de Membrana Transportadoras/genética , Tailândia , /genética
14.
BMC Pharmacol Toxicol ; 14: 16, 2013 Mar 08.
Artigo em Inglês | MEDLINE | ID: mdl-23497690

RESUMO

BACKGROUND: Healthcare professional's knowledge and attitudes to adverse drug reaction (ADR) and ADR reporting play vital role to report any cases of ADR. Positive attitudes may favour ADR reporting by healthcare professionals. This study was aimed to investigate the attitudes towards and ways to improve adverse drug reaction (ADR) reporting among healthcare professionals working at four Regional Pharmacovigilance Centres (RPCs) of Nepal. METHODS: A cross sectional study was done by survey using a self-administered structured questionnaire. The questionnaire was distributed to 450 healthcare professionals working at four RPCs. RESULTS: The overall response rate was 74.0%. There were 74.8% of healthcare professionals who had seen patient experiencing an ADR; however, only 20.1% had reported. Reporting form not available (48.1%) and other colleagues not reporting ADR cases (46.9%) would significantly discourage the ADR reporting among healthcare professionals working at four RPCs. Healthcare professionals perceived that seriousness of the reaction (75.6%); unusual reaction (64.6%); reaction to new product (71.2%); new reaction to existing product (70.2%); and confidence in diagnosis of ADR (60.8%) were important factors on the decision to report ADR. Awareness among healthcare professionals (85.9%), training (76.0%), collaboration (67.0%), and involve pharmacist for ADR reporting (63.1%) were mostly recognized ways to improve reporting. Regular newsletter on current awareness in drug safety (71.2%), information on new ADR (65.8%), and international drug safety information (64.0%) were the identified feedbacks they would like to receive from the Nepal pharmacovigilance programme. CONCLUSION: Healthcare professionals working at four RPCs of Nepal have positive attitudes towards ADR reporting. Awareness among healthcare professionals, training and collaboration would likely improve reporting provided they would receive appropriate feedback from the national pharamcovigilance programme.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Atitude do Pessoal de Saúde , Pessoal de Saúde/estatística & dados numéricos , Adulto , Feminino , Pessoal de Saúde/psicologia , Hospitais/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Nepal , Farmacovigilância , Inquéritos e Questionários , Adulto Jovem
15.
Int J Risk Saf Med ; 25(1): 1-16, 2013 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-23442293

RESUMO

OBJECTIVE: To investigate the knowledge about ADRs and ADR reporting among healthcare professionals working at four regional pharmacovigilance centers (RPCs) of Nepal. METHODS: It was a cross sectional study, done by a survey using a validated self-administered structured questionnaire. The questionnaire was distributed to 450 healthcare professionals working at four RPCs. RESULTS: The overall response rate was 74%. Only 53% and 38% of respondents knew about the existence of National Pharmacovigilance Centre (NPC) and RPC, respectively. Among the respondents, 29% and 33% did not know what a Type A and Type B ADR was. Similarly, 30% and 45% were not aware of the common types of ADRs or the thalidomide tragedy. Only, 9% knew about Uppsala Monitoring Centre (UMC) and only 10% answered correctly about the Naranjo algorithm as a causality assessment tool for ADRs. Of the respondents, only 19% knew about spontaneous reporting system and only 18% were aware about its drawbacks. The overall mean score on knowledge about ADR among healthcare professionals was 7.64 ± 2.38 out of the maximum possible score of 12. Whereas, the overall mean score of knowledge about ADR reporting was 3.95 ± 1.78 out of maximum possible score of 11. CONCLUSION: Healthcare professionals working at four RPCs of Nepal have some knowledge about ADRs themselves but limited knowledge about ADR reporting. There is an urgent need of action to be taken by RPCs at the regional level and NPC at the national level to improve knowledge and ADR reporting by healthcare professionals.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Conhecimentos, Atitudes e Prática em Saúde , Farmacovigilância , Adulto , Estudos Transversais , Feminino , Pesquisas sobre Atenção à Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Nepal , Enfermeiras e Enfermeiros , Farmacêuticos , Médicos
16.
Int J Infect Dis ; 16(12): e843-9, 2012 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-22951426

RESUMO

OBJECTIVES: To compare the clinical and bacteriological effectiveness of intravenous (IV) ceftriaxone followed by oral cefditoren pivoxil or IV ceftriaxone for acute pyelonephritis. METHODS: A prospective randomized controlled trial of patients with a presumptive diagnosis of acute pyelonephritis was performed. Daily 2g IV ceftriaxone was initially given to all patients. After day 3, patients who satisfied the criteria for switch therapy were randomized to either group A (IV ceftriaxone) or group B (oral cefditoren pivoxil 400mg once daily). RESULTS: Eighty-two patients were enrolled; 41 (50%) patients in group A and 41 (50%) patients in group B were evaluated. There was no statistically significant difference in baseline characteristics between the two groups. Clinical cure was observed in 39 of 41 (95.1%) patients in group A and 41 of 41 (100%) patients in group B (p=0.15, 95% confidence interval (CI) -0.12 to 0.02). Urine bacteriological eradication was found in 63.4% in group A and 60% in group B (p=0.75, 95% CI -0.18 to 0.25). There was no statistically significant difference in adverse effects between the two treatment groups. CONCLUSION: These data suggest that IV ceftriaxone followed by oral cefditoren pivoxil is highly effective and well-tolerated for the treatment of acute pyelonephritis, even for uropathogens with a high proportion of quinolone-resistant strains.


Assuntos
Antibacterianos/administração & dosagem , Ceftriaxona/administração & dosagem , Cefalosporinas/administração & dosagem , Pielonefrite/tratamento farmacológico , Doença Aguda , Administração Intravenosa , Administração Oral , Adulto , Idoso , Antibacterianos/efeitos adversos , Ceftriaxona/efeitos adversos , Cefalosporinas/efeitos adversos , Método Duplo-Cego , Substituição de Medicamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento
17.
Int J Rheum Dis ; 15(3): 315-21, 2012 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-22709494

RESUMO

AIM: We aimed to determine the prevalence and characteristics of adverse drug events (ADE) in rheumatoid arthritis (RA) and (osteoarthritis) OA patients. METHOD: A cross-sectional study at rheumatology clinics, was performed by random selection of RA and OA out-patients by a research pharmacist. All suspected ADEs occurring during the last hospital visit and the subjects were identified by retrospective chart review and direct patient interview. ADE characteristics, including causative drug groups, affected organ severity and patient outcomes, were recorded. RESULTS: One hundred and forty-three patients consisting of 129 RA and 14 OA were recruited. The patients' mean ages were 54.3 ± 14.3 years and 121 (84.6%) patients were female. A total of 68 ADEs were detected in 51 patients. The prevalence and rate of ADE were 35.7% and 47.6 events per 100 patients, respectively. Thirty out of 68 ADEs (44.1%) were preventable. Disease-modifying anti-rheumatic drugs and non-steroidal anti-inflammatory drugs resulted in ADEs by 41 (59.4%) and 10 (14.5%) events, respectively. Common affected organs were skin, gastrointestinal tract and eyes which accounted for 20 (29.4%), 18 (26.5%) and eight events (11.6%), respectively. Continuation of the suspected drug was noted in 42 ADEs (61.8%), classified as severity level 1 and 2a-b, and 43 ADEs (63.2%) were completely or partially resolved during the study period. CONCLUSION: ADEs are common in RA and OA patients with prevalence of 35.7%. High exposure to potentially harmful drugs might explain the higher rate of ADE in these patients.


Assuntos
Assistência Ambulatorial , Anti-Inflamatórios não Esteroides/efeitos adversos , Antirreumáticos/efeitos adversos , Artrite Reumatoide/tratamento farmacológico , Osteoartrite/tratamento farmacológico , Adulto , Idoso , Artrite Reumatoide/diagnóstico , Artrite Reumatoide/epidemiologia , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Osteoartrite/diagnóstico , Osteoartrite/epidemiologia , Prevalência , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Tailândia/epidemiologia
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