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1.
Regen Med ; 15(1): 1215-1227, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32103712

RESUMO

Aim: We investigated publication rates and reported results for gene- and cell-based therapy trials. Materials & methods: In a cohort of Institutional Review Board (IRB)-authorized trials during 2007-2017 in the Netherlands (n = 105), we examine publication rates and reported results in scientific papers and conference abstracts as well as associations with the occurrence of trial characteristics. Results: The publication rate for scientific papers was 27% and 17% for conference abstracts (median survival time: 1050 days). Academic hospitals published more in scientific papers whereas private sponsors published more in conference abstracts. Manufacturing protocols were underreported compared with clinical outcomes. Most publications reported positive results (78%). Conclusion: Publication rates are currently suboptimal indicating a need for enhanced knowledge sharing to stimulate gene- and cell-based therapy development.

2.
Clin Interv Aging ; 14: 535-547, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30880934

RESUMO

Purpose: Cardiovascular diseases (CVDs) are extremely common among the elderly, but information on the use of potentially inappropriate medications (PIMs) with cardiovascular risk is scarce. We aimed to determine the prevalence of PIMs with risk of cardiac and cerebrovascular adverse events (CCVAEs), including major adverse cardiac and cerebrovascular events (MACCE). Patients and methods: A cross-sectional study was performed using a convenience sample from four long-term care facilities and one community pharmacy in Portugal. Patients were included if they were aged 65 or older and presented at least one type of medication in their medical and pharmacotherapeutic records from 2015 until December 2017. The main outcome was defined as the presence of PIMs with risk of MACCE and was assessed by applying a PIM-MACCE list that was developed from a previous study. All medications included in this list were assessed for their availability in Portugal. Results: A total of 680 patients were included. Of those, 428 (63%) were female with a mean age of 78.4±8.1 years. Four-hundred and four (59.4%) patients were taking medications associated with CCVAEs risk (mean =1.7±1.0 drugs/patient), including 264 patients (38.8%) who used drugs with MACCE risk (mean =1.4±0.8 drugs/patient). Fifty percent of patients with a previous history of CVD (n=521) were taking PIMs with risk of CCVAEs, including 30.0% with risk of MACCE. Conclusion: Our findings show that 50% of patients with previous history of CVD were taking drugs with risk of CCAVEs and 30% with risk of MACCE. More tailored tools for the management of drug therapy in elderly patients with CVD are of major importance in clinical practice.


Assuntos
Doenças Cardiovasculares/induzido quimicamente , Assistência de Longa Duração , Lista de Medicamentos Potencialmente Inapropriados/estatística & dados numéricos , Instituições de Cuidados Especializados de Enfermagem , Idoso , Idoso de 80 Anos ou mais , Fármacos Cardiovasculares/efeitos adversos , Doenças Cardiovasculares/prevenção & controle , Estudos Transversais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Feminino , Humanos , Prescrição Inadequada/estatística & dados numéricos , Masculino , Portugal , Prevalência , Estudos Retrospectivos
3.
Int J Pharm ; 517(1-2): 128-134, 2017 Jan 30.
Artigo em Inglês | MEDLINE | ID: mdl-27931784

RESUMO

Usability is a key factor in ensuring safe and efficacious use of medicines. However, several studies showed that people experience a variety of problems using their medicines. The purpose of this study was to identify design features of oral medicines that cause use problems among older patients in daily practice. A qualitative study with semi-structured interviews on the experiences of older people with the use of their medicines was performed (n=59). Information on practical problems, strategies to overcome these problems and the medicines' design features that caused these problems were collected. The practical problems and management strategies were categorised into 'use difficulties' and 'use errors'. A total of 158 use problems were identified, of which 45 were categorized as use difficulties and 113 as use error. Design features that contributed the most to the occurrence of use difficulties were the dimensions and surface texture of the dosage form (29.6% and 18.5%, respectively). Design features that contributed the most to the occurrence of use errors were the push-through force of blisters (22.1%) and tamper evident packaging (12.1%). These findings will help developers of medicinal products to proactively address potential usability issues with their medicines.


Assuntos
Formas de Dosagem , Embalagem de Medicamentos , Cooperação do Paciente , Preparações Farmacêuticas , Idoso , Idoso de 80 Anos ou mais , Embalagem de Medicamentos/métodos , Embalagem de Medicamentos/normas , Feminino , Humanos , Masculino , Preparações Farmacêuticas/administração & dosagem , Preparações Farmacêuticas/química , Polimedicação
4.
Patient Prefer Adherence ; 10: 2369-2377, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27920503

RESUMO

PURPOSE: The health-related quality of life (HRQoL) of patients completing multidrug-resistant tuberculosis (MDR-TB) treatment in Namibia and whether the occurrence of adverse events influenced patients' rating of their HRQoL was evaluated. PATIENTS AND METHODS: A cross-sectional analytic survey of patients completing or who recently completed MDR-TB treatment was conducted. The patients rated their HRQoL using the simplified Short Form-™ (SF-8) questionnaire consisting of eight Likert-type questions. Three supplemental questions on the adverse events that the patients may have experienced during their MDR-TB treatment were also included. Scoring of HRQoL ratings was norm-based (mean =50, standard deviation =10) ranging from 20 (worst health) to 80 (best health), rather than the conventional 0-100 scores. We evaluated the internal consistency of the scale items using the Cronbach's alpha, performed descriptive analyses, and analyzed the association between the patients' HRQoL scores and adverse events. RESULTS: Overall, 36 patients (20 males, 56%) aged 17-54 years (median =40 years) responded to the questionnaire. The median (range) HRQoL score for the physical component summary was 58.6 (35.3-60.5), while the median score for the mental component summary was 59.3 (26.6-61.9), indicating not-so-high self-rating of health. There was good internal consistency of the scale scores, with a Cronbach's alpha value of >0.80. In all, 32 (89%) of the 36 patients experienced at least one adverse drug event of any severity during their treatment (median events =3, range 1-6), of which none was life-threatening. The occurrence of adverse events was not related to HRQoL scores. For patients reporting zero to two events, the median (range) HRQoL score was 56.8 (44.4-56.8), while for those reporting three or more events, the median score was 55.2 (38.6-56.8); P=0.34 for difference between these scores. CONCLUSION: Patients completing treatment for MDR-TB in Namibia tended to score moderately low on their HRQoL, using the generic SF-8 questionnaire. The occurrence of adverse events did not lead to lower HRQoL scores upon treatment completion.

5.
Artigo em Inglês | MEDLINE | ID: mdl-24764540

RESUMO

OBJECTIVES: Continuous provision of appropriate medicines of assured quality, in adequate quantities, and at reasonable prices is a concern for all national governments. A national medicines policy (NMP) developed in a collaborative fashion identifies strategies needed to meet these objectives and provides a comprehensive framework to develop all components of a national pharmaceutical sector. To meet the health needs of the population, there is a general need for medicine policies based on universal principles, but nevertheless adapted to the national situation. This review aims to provide a quantitative and qualitative (describing the historical development) study of the development process and evolution of NMPs. METHODS: The number of NMPs and their current status has been obtained from the results of the assessment of WHO Level I indicators. The policy formulation process is examined in more detail with case studies from four countries: Sri Lanka, Australia, former Yugoslav Republic of Macedonia and South Africa. RESULTS: The number of NMPs worldwide has increased in the last 25 years with the highest proportional increase in the last 5-10 years in high-income countries. Higher income countries seem to have more NMP implementation plans available and have updated their NMP more recently. The four case studies show that the development of a NMP is a complex process that is country specific. In addition, it demonstrates that an appropriate political window is needed for the policy to be passed (for South Africa and the FYR Macedonia, a major political event acted as a trigger for initiating the policy development). Policy-making does not stop with the official adoption of a policy but should create mechanisms for implementation and monitoring. The NMPs of the FYR Macedonia and Australia provide indicators for monitoring. CONCLUSIONS: To date, not all countries have a NMP since political pressure by national experts or non-governmental organizations is generally needed to establish a NMP. Case studies in four countries showed that the policy process is just as important as the policy document since the process must create a mechanism by which all stakeholders are brought together and a sense of collective ownership of the final policy may be achieved.

6.
Emerg Themes Epidemiol ; 7(1): 2, 2010 May 14.
Artigo em Inglês | MEDLINE | ID: mdl-20470397

RESUMO

BACKGROUND: Laboratory testing in clinical practice is never a random process. In this study we evaluated testing bias for neutrophil counts in clinical practice by using results from requested and non-requested hematological blood tests. METHODS: This study was conducted using data from the Utrecht Patient Oriented Database. This clinical database is unique, as it contains physician requested data, but also data that are not requested by the physician, but measured as result of requesting other hematological parameters. We identified adult patients, hospitalized in 2005 with at least two blood tests during admission, where requests for general blood profiles and specifically for neutrophil counts were contrasted in scenario analyses. Possible effect modifiers were diagnosis and glucocorticoid use. RESULTS: A total of 567 patients with requested neutrophil counts and 1,439 patients with non-requested neutrophil counts were analyzed. The absolute neutrophil count at admission differed with a mean of 7.4 x 109/l for requested counts and 8.3 x 109/l for non-requested counts (p-value < 0.001). This difference could be explained for 83.2% by the occurrence of cardiovascular disease as underlying disease and for 4.5% by glucocorticoid use. CONCLUSION: Requests for neutrophil counts in clinical databases are associated with underlying disease and with cardiovascular disease in particular. The results from our study show the importance of evaluating testing bias in epidemiological studies obtaining data from clinical databases.

7.
Ann Pharmacother ; 44(2): 267-73, 2010 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-20071496

RESUMO

BACKGROUND: Hospitalizations have always been seen as a solid outcome parameter in pharmacoepidemiology. However, the period leading to hospitalization and prehospital management of the patient are equally important. OBJECTIVE: To evaluate medication changes in the period prior to hospitalization for obstructive lung disease and to quantify the association between medication use and the risk of hospitalization. METHODS: We conducted a case-crossover study using the PHARMO record linkage system, which contains drug dispensing data from community pharmacies and hospital admission data. Patients included in the study were adults hospitalized for obstructive lung disease between 2005 and 2007. The index date of the case period was the date of hospitalization, and control moments were set at 3, 6, 9, and 12 months before admission. For each patient, all prescriptions prior to the date of hospitalization were identified. Medication use was ascertained in a 90-day time window prior to each case or control moment. RESULTS: We identified 1481 patients who were hospitalized for obstructive lung disease. It appeared that respiratory medication use increased in the 90 days prior to hospitalization. Hospitalization was associated with the use of 3 or more respiratory drugs (OR 2.2; 95% CI 1.8 to 2.8), systemic glucocorticoids (OR 4.5; 95% CI 3.8 to 5.4), and antibiotics (OR 3.1; 95% CI 2.7 to 3.6). CONCLUSIONS: The use of systemic glucocorticoids, antibiotics, and other respiratory drugs increased prior to hospitalization for obstructive lung disease. These results could be indicative of the development and/or treatment of an exacerbation. There is a need for markers to detect exacerbations in an early phase in order to start treatment as early as possible and possibly prevent hospitalizations for obstructive lung disease.


Assuntos
Antibacterianos/uso terapêutico , Glucocorticoides/uso terapêutico , Hospitalização/estatística & dados numéricos , Pneumopatias Obstrutivas/tratamento farmacológico , Adolescente , Adulto , Idoso , Estudos Cross-Over , Bases de Dados Factuais , Feminino , Humanos , Pneumopatias Obstrutivas/fisiopatologia , Masculino , Pessoa de Meia-Idade , Países Baixos , Adulto Jovem
8.
Int J Equity Health ; 8: 43, 2009 Dec 14.
Artigo em Inglês | MEDLINE | ID: mdl-20003422

RESUMO

BACKGROUND: A rural pharmacy initiative (RPI) designed to increase access to medicines in rural Kyrgyzstan created a network of 12 pharmacies using a revolving drug fund mechanism in 12 villages where no pharmacies previously existed. The objective of this study was to determine if the establishment of the RPI resulted in the unforeseen benefit of triggering medicine price competition in pre-existing (non-RPI) private pharmacies located in the region. METHODS: We conducted descriptive and multivariate analyses on medicine insurance claims data from Kyrgyzstan's Mandatory Health Insurance Fund for the Jumgal District of Naryn Province from October 2003 to December 2007. We compared average quarterly medicine prices in competitor pharmacies before and after the introduction of the rural pharmacy initiative in October 2004 to determine the RPI impact on price competition. RESULTS: Descriptive analyses suggest competitors reacted to RPI prices for 21 of 30 (70%) medicines. Competitor medicine prices from the quarter before RPI introduction to the end of the study period decreased for 17 of 30 (57%) medicines, increased for 4 of 30 (13%) medicines, and remained unchanged for 9 of 30 (30%) medicines. Among the 9 competitor medicines with unchanged prices, five initially decreased in price but later reverted back to baseline prices. Multivariate analyses on 19 medicines that met sample size criteria confirm these findings. Fourteen of these 19 (74%) competitor medicines changed significantly in price from the quarter before RPI introduction to the quarter after RPI introduction, with 9 of 19 (47%) decreasing in price and 5 of 19 (26%) increasing in price. CONCLUSIONS: The RPI served as a market driver, spurring competition in medicine prices in competitor pharmacies, even when they were located in different villages. Initiatives designed to increase equitable access to medicines in rural regions of developing and transitional countries should consider the potential to leverage medicine price competition as a means of achieving their goal. Evaluations of interventions to increase rural access to medicines should include impact assessment on both formal and informal pharmaceutical markets.

9.
Ann Pharmacother ; 40(6): 1040-6, 2006 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-16735666

RESUMO

BACKGROUND: The chemical structure of sulfonamide antibiotics and sulfonamide nonantibiotics can affect the potential for adverse reactions. OBJECTIVE: To assess whether differences in chemical structure of the various sulfonamide drugs influence the risk of allergic events. METHODS: A case-control study was conducted among patients with diabetes mellitus (DM) using data from the General Practice Research Database. Cases were defined as patients with a diagnosis of hypersensitivity or allergic reaction. The date of the last event was the index date. Controls were matched on practice, type of DM, and index date. Current use of sulfonamides was defined as use in a 14 day time window before the index date. Sulfonamides were classified according to the presence/absence of an N1 substituent (N1(+)/(-)) and/or an arylamine (N4(+)/(-)). Conditional logistic regression was used to estimate strength of association and expressed as odds ratios and 95% confidence intervals. RESULTS: Overall, current use of N1(+) N4(+) sulfonamide drugs was associated with the outcome (adjusted OR 3.71; 95% CI 1.40 to 9.81). Current use of N1(+) N4(-) and N1(-) N4(-) sulfonamide drugs was also associated with the occurrence of allergic reactions, although not as strongly: adjusted OR 2.48 (95% CI 2.12 to 2.89) and 2.07 (95% CI 1.74 to 2.46), respectively. Sex and age seemed to be effect modifiers. There was no clear evidence for effect modification by immune disease state. CONCLUSIONS: Although we did not identify major differences between the groups, we believe that this approach is an innovative manner to examine adverse drug reactions by using chemical structure instead of therapeutic drug classes to classify exposure.


Assuntos
Anti-Infecciosos/efeitos adversos , Anti-Infecciosos/química , Hipersensibilidade a Drogas/epidemiologia , Sulfonamidas/efeitos adversos , Sulfonamidas/química , Idoso , Estudos de Casos e Controles , Bases de Dados Factuais , Complicações do Diabetes/terapia , Hipersensibilidade a Drogas/imunologia , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Risco , Relação Estrutura-Atividade
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