Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 13 de 13
Filtrar
1.
Eur J Pain ; 2024 Jun 05.
Artigo em Inglês | MEDLINE | ID: mdl-38838067

RESUMO

BACKGROUND: The present study sought to determine the prevalence of chronic non-cancer pain (CNCP) among older adult inpatients with polypharmacy. It also aimed to analyse prescription patterns and assess the therapy adequacy and patient complexity for those with and without CNCP. METHODS: This 4-year longitudinal study examined data from an exhaustive acute care hospital register on home-dwelling older adult patients (≥65) with polypharmacy. Commonly known combinations of potentially inappropriate medications were used to estimate therapy adequacy. Patient complexity was evaluated by comparing number of comorbidities and investigating physical and cognitive deficits. RESULTS: We determined a prevalence of CNCP of 9.7% among all older adult inpatients with polypharmacy, rising to 11.3% for those aged ≥85. Overall, CNCP patients were prescribed more drugs and had more comorbidities and physical and cognitive deficits than patients without CNCP. Older adult patients with CNCP received more analgesics, greater quantities of opioids, paracetamol and co-analgesics and elevated opioid dosages. Older adult patients with CNCP aged ≥85 received fewer analgesics, opioids, non-steroidal anti-inflammatory drugs and co-analgesics but more paracetamol. Older adult patients with CNCP were prescribed more potentially inappropriate medications involving opioids. In particular, 24.5% received an opioid and a hypnotic (benzodiazepine or Z-drug), and 8.6% received an opioid and a gabapentinoid. CONCLUSION: Observed differences in medication use between older adult inpatients with or without CNCP may be relevant for clinical practice. Potentially inadequate co-prescribing (such as hypnotics and opioids) affects a higher proportion of patients with CNCP and may have serious unintended consequences. SIGNIFICANCE STATEMENT: This study describes differences in prescription patterns between people with and without chronic non-cancer pain in a large dataset of 20,422 discharges. The differences found may be relevant to clinical practice. In particular, high co-prescribing of opioids and hypnotics may have serious unintended consequences. Greater physical and cognitive deficits may indicate greater patient complexity, and appropriate interventions need to be developed to improve the management of this vulnerable patient group.

2.
BMC Health Serv Res ; 24(1): 367, 2024 Mar 22.
Artigo em Inglês | MEDLINE | ID: mdl-38519949

RESUMO

BACKGROUND: Homecare client services are often distributed across several interdependent healthcare providers, making proper care coordination essential. However, as studies exploring care coordination in the homecare setting are scarce, serious knowledge gaps exist regarding how various factors influence coordination in this care sector. To fill such gaps, this study's central aim was to explore how external factors (i.e., financial and regulatory mechanisms) and homecare agency characteristics (i.e., work environment, workforce, and client characteristics) are related to care coordination in homecare. METHODS: This analysis was part of a national multicentre, cross-sectional study in the Swiss homecare setting that included a stratified random sample of 88 Swiss homecare agencies. Data were collected between January and September 2021 through agency and employee questionnaires. Using our newly developed care coordination framework, COORA, we modelled our variables to assess the relevant components of care coordination on the structural, process, and outcome levels. We conducted both descriptive and multilevel regression analyses-with the latter adjusting for dependencies within agencies-to explore which key factors are associated with coordination. RESULTS: The final sample size consisted of 1450 employees of 71 homecare agencies. We found that one explicit coordination mechanism ("communication and information exchange" (beta = 0.10, p <.001)) and four implicit coordination mechanisms-"knowledge of the health system" (beta = -0.07, p <.01), "role clarity" (beta = 0.07, p <.001), "mutual respect and trust" (beta = 0.07, p <.001), and "accountability, predictability, common perspective" (beta = 0.19, p <.001)-were significantly positively associated with employee-perceived coordination. We also found that the effects of agency characteristics and external factors were mediated through coordination processes. CONCLUSION: Implicit coordination mechanisms, which enable and enhance team communication, require closer examination. While developing strategies to strengthen implicit mechanisms, the involvement of the entire care team is vital to create structures (i.e., explicit mechanisms) that enable communication and information exchange. Appropriate coordination processes seem to mitigate the association between staffing and coordination. This suggests that they support coordination even when workload and overtime are higher.


Assuntos
Serviços de Assistência Domiciliar , Humanos , Estudos Transversais , Inquéritos e Questionários , Cuidados Paliativos
3.
Res Social Adm Pharm ; 20(6): 92-101, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38433064

RESUMO

BACKGROUND: Medication-related readmissions challenge healthcare systems by burdening patients, increasing costs and straining resources. However, to date, there has been no consensus study on indicators for medication-related readmissions. OBJECTIVES: This Delphi study aimed to develop a consensus-based set of indicators for detecting patients at risk of medication-related readmission. METHODS: An expert panel of clinical pharmacists, physicians and nursing experts participated in a two-round Delphi study. In round 1, 31 indicators taken from the literature were rated for relevance on a scale from 1 to 9, with a median rating of 7 or higher suggesting relevance. The RAND/UCLA method was used to determine consensus. In round 2, indicators lacking consensus were re-rated together with a series of new indicators generated by the experts. Additional details were sought for some indicators. The main outcomes were the relevance of, consensus on, and completeness of the proposed indicators for identifying risks of 30-day medication-related readmission. RESULTS: Thirty-eight experts participated in round 1. Consensus was found for all the indicators, with 25 included and 6 excluded. Thirty-four experts participated in round 2. Consensus was found for all 5 newly suggested indicators, and 4 were included. The expert panel prioritized the following indicators: (1) insufficient communication between different healthcare providers, (2) polypharmacy (≥7 medications), (3) low rates of medication adherence (twice-weekly mistakes or missing administration), (4) complex medication regimens (≥3 doses, ≥2 dosage forms and ≥2 administration routes per day), and (5) multimorbidity (≥3 chronic conditions). The final set comprised 29 indicators. CONCLUSIONS: The indicator set developed for flagging potential medication-related readmissions could guide priorities for clinical pharmacy services at hospital discharge, improving patient outcomes and resource use. A validation study of these indicators is planned.


Assuntos
Consenso , Técnica Delphi , Readmissão do Paciente , Farmacêuticos , Humanos , Readmissão do Paciente/estatística & dados numéricos , Farmacêuticos/organização & administração , Feminino , Masculino , Médicos
4.
Int J Clin Pharm ; 45(3): 577-586, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-36773207

RESUMO

BACKGROUND: Pharmacists contribute to medication safety by providing their services in various settings. However, standardized definitions of the role of pharmacists in hospice and palliative care (HPC) are lacking. AIM: The purpose of this scoping review was to provide an overview of the evidence on the role of pharmacists and to map clinical activities in inpatient HPC. METHOD: We performed a scoping review according to the PRISMA-ScR extension in CINAHL, Embase, and PubMed. We used the American Society of Hospital Pharmacists (ASHP) Guidelines on the Pharmacist's Role in Palliative and Hospice Care as a framework for standardized categorization of the identified roles and clinical activities. RESULTS: After screening 635 records (published after January 1st, 2000), the scoping review yielded 23 publications reporting various pharmacy services in HPC. The articles addressed the five main categories in the following descending order: 'Medication order review and reconciliation', 'Medication counseling, education and training', 'Administrative Roles', 'Direct patient care', and 'Education and scholarship'. A total of 172 entries were mapped to the subcategories that were added to the main categories. CONCLUSION: This scoping review identified a variety of pharmacists' roles and clinical activities. The gathered evidence will help to establish and define the role of pharmacists in inpatient hospice and palliative care.


Assuntos
Hospitais para Doentes Terminais , Serviço de Farmácia Hospitalar , Humanos , Pacientes Internados , Cuidados Paliativos , Farmacêuticos , Papel Profissional
5.
Artigo em Inglês | MEDLINE | ID: mdl-36767067

RESUMO

Ageing is frequently associated with multimorbidity and polypharmacy. The present study aimed to identify the current medication management patterns and the profiles of home-dwelling older adults and to find any association with their conditions, including frailty and cognitive impairment. Within the scope of this cross-sectional study, 112 older adults living in the community were assessed via face-to-face structured interviews. Frailty, cognitive status, medication management and clinical and sociodemographic variables were evaluated. Descriptive and inferential statistics were calculated. The mean participant age was 76.6 ± 7.1 years, 53.6% of participants were women, and 40.2% of participants lived alone. More than half were classified as having frailty (58.9%), almost one-fifth (19.6%) presented with a moderate cognitive impairment had more than one disease, and 60.7% were polymedicated. No associations were found between polymedication and medication self-management, the use of over-the-counter medications, living alone, having a poor understanding of pharmacological therapy and/or pathology, or having more than one prescriber. Self-management was associated with age, the number of medications, frailty and cognitive status. Binary logistic regressions showed that cognitive impairment had statistically significant differences with medication management, having a poor understanding of pharmacological therapy and/or pathology, having one prescriber and the use of medications not prescribed by physicians. Interventions to prevent medication-related problems in home-dwelling older adults are recommended.


Assuntos
Disfunção Cognitiva , Fragilidade , Humanos , Feminino , Idoso , Idoso de 80 Anos ou mais , Masculino , Fragilidade/epidemiologia , Estudos Transversais , Conduta do Tratamento Medicamentoso , Portugal/epidemiologia , Disfunção Cognitiva/epidemiologia , Vida Independente
6.
JMIR Res Protoc ; 12: e39130, 2023 Jan 25.
Artigo em Inglês | MEDLINE | ID: mdl-36696165

RESUMO

BACKGROUND: Effective medication management is one of the essential preconditions for enabling polymedicated home-dwelling older adults with multiple chronic conditions to remain at home and preserve their quality of life and autonomy. Lack of effective medication management predisposes older adults to medication-related problems (MRPs) and adverse health outcomes, which can lead to the degradation of a patient's acute clinical condition, physical and cognitive decline, exacerbation of chronic medical conditions, and avoidable health care costs. Nonetheless, it has been shown that MRPs can be prevented or reduced by using well-coordinated, patient-centered, interprofessional primary care interventions. OBJECTIVE: This study aimed to explore the feasibility and acceptability of an evidence-based, multicomponent, interprofessional intervention program supported by informal caregivers to decrease MRPs among polymedicated home-dwelling older adults with multiple chronic conditions. METHODS: This quasi-experimental, pre-post, multisite pilot, and feasibility study will use an open-label design, with participants knowing the study's objectives and relevant information, and it will take place in primary health care settings in Portugal and Switzerland. The research population will comprise 30 polymedicated, home-dwelling adults, aged ≥65 years at risk of MRPs and receiving community-based health care, along with their informal caregivers and health care professionals. RESULTS: Before a projected full-scale study, this pilot and feasibility study will focus on recruiting and ensuring the active collaboration of its participants and on the feasibility of expanding this evidence-based, multicomponent, interprofessional intervention program throughout both study regions. This study will also be essential to projected follow-up research programs on informal caregivers' multiple roles, enhancing their coordination tasks and their own needs. Results are expected at the end of 2024. CONCLUSIONS: Designing, establishing, and exploring the feasibility and acceptability of an intervention program to reduce the risks of MRPs among home-dwelling older adults is an underinvestigated issue. Doing so in collaboration with all the different actors involved in that population's medication management and recording the first effects of the intervention will make this pilot and feasibility study's findings very valuable as home care becomes an ever more common solution. TRIAL REGISTRATION: Swiss National Clinical Trials Portal 000004654; https://tinyurl.com/mr3yz8t4.

7.
Am J Hosp Palliat Care ; 40(8): 820-828, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-36168963

RESUMO

BACKGROUND: In hospice and palliative care, drug therapy is essential for symptom control. However, drug regimens are complex and prone to drug-related problems. Drug regimens must be simplified to improve quality of life and reduce risks associated with drug-related problems, particularly at end-of-life. To support clinical guidance towards a safe and effective drug therapy in hospice care, it is important to understand prescription trends. OBJECTIVES: To explore prescription trends and describe changes to drug regimens in inpatient hospice care. DESIGN: We performed a retrospective longitudinal and descriptive analysis of prescriptions for regular and as-needed (PRN) medication at three timepoints in deceased patients of one Swiss hospice. SETTING/SUBJECTS: Prescription records of all patients (≥ 18 years) with an inpatient stay of three days and longer (admission and time of death in 2020) were considered eligible for inclusion. RESULTS: Prescription records of 58 inpatients (average age 71.7 ± 12.8 [37-95] years) were analyzed. The medication analysis showed that polypharmacy prevalence decreased from 74.1% at admission to 13.8% on the day of death. For regular medication, overall numbers of prescriptions decreased over the patient stay while PRN medication decreased after the first consultation by the attending physician and increased slightly towards death. CONCLUSIONS: Prescription records at admission revealed high initial rates of polypharmacy that were reduced steadily until time of death. These findings emphasize the importance of deprescribing at end-of-life and suggest pursuing further research on the contribution of clinical guidance towards optimizing drug therapy and deprescribing in inpatient hospice care.


Assuntos
Cuidados Paliativos na Terminalidade da Vida , Humanos , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Estudos Retrospectivos , Qualidade de Vida , Prescrições , Morte
8.
J Adv Nurs ; 78(12): 4210-4220, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36052608

RESUMO

AIM: To develop a consensus-based instrument [MELIA] to assess the medication literacy of older home care patients to ultimately optimize medication safety. DESIGN: This study was part of the project 'Study of Medication Safety in Home Care' (doMESTIC), which took place from 2016 to 2020 in Switzerland. The development process for the medication literacy assessment instrument encompassed six steps. METHOD: First, a scoping literature search was conducted in the Pubmed, CINAHL, EMBASE and Cochrane Library databases as 2) a basis for the development of assessment items. This was followed by 3) a cognitive interview with home care patients and 4) the first round of a Delphi process. Then, 5) a focus group interview with home care experts was conducted before 6) the second Delphi round. The project took place between August 2020 and June 2021. With these different steps, perspectives of both patients and various home care and medication safety experts were included in the development of the assessment instrument. RESULTS: A detailed instrument consisting of 20 items as well as a 7-item short version were developed. The short version is intended for efficient preliminary screening to identify patients at high risk for medication management-related problems. CONCLUSION: Medication literacy in patients 65 years and older receiving professional home care is a key issue in preventing medication errors. A targeted assessment, starting with an efficient short version of MELIA, allows for prioritization of patients for interventions to optimize medication safety while ensuring their independence as much as possible. IMPACT: Systematic assessment of patients' medication literacy helps to provide them with targeted and individual support in their medication management to avoid medication errors and increase patient safety. The development of MELIA is a first step in providing an assessment instrument specifically for the home care setting. PATIENT OR PUBLIC CONTRIBUTION: Patient participation was an integral part of the instrument development. The initial 23 items were optimized based on cognitive interviews with four home care patients. The next steps of the instrument development were based on feedback of health care professionals-encompassing advance practice nurses, regular nurses, pharmacists and general practitioners-during a two-step Delphi process as well as a focus group discussion.


Assuntos
Serviços de Assistência Domiciliar , Melia , Humanos , Idoso , Alfabetização , Farmacêuticos , Erros de Medicação/prevenção & controle
9.
J Pain Symptom Manage ; 64(5): e250-e259, 2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-35870656

RESUMO

BACKGROUND: Subcutaneous drug administration is an interesting approach for symptom control in hospice and palliative care. However, most drugs have no marketing authorization for subcutaneous administration and are therefore used off-label. In order to meet the requirements of a safe and effective drug therapy, especially in highly vulnerable patients, it is essential to investigate the scope of evidence of these common practices. OBJECTIVES: The purpose of this scoping review was to provide an overview of available data on the tolerability and/or effectiveness of subcutaneously administered and off-label used drugs. METHOD: We performed a scoping review according to the PRISMA extension to identify data available on the tolerability and/or effectiveness of 17 predefined drugs that are commonly administered subcutaneously in Swiss hospices and hospice-like institutions and that have no marketing authorization (off-label use). RESULTS: The scoping review identified 57 studies with most data available on their tolerability (68% local, 54% systemic), clinical effects (82%), details on dosage (96%) and routes of application (100%). Information on pharmacokinetic properties was mostly missing and only available for fentanyl, levetiracetam, midazolam, and ondansetron. For seven drugs, less than five articles were identified and no studies on codeine or clonazepam were available. CONCLUSION: This work provides an overview of current evidence on subcutaneous and off-label used drugs in hospice and palliative care. Although both are common practices, evidence on tolerability and effectiveness, particularly pharmacokinetic data, is limited and the identified information gaps need to be closed. This work establishes a basis for further research in this area.


Assuntos
Cuidados Paliativos na Terminalidade da Vida , Hospitais para Doentes Terminais , Clonazepam , Codeína , Fentanila , Humanos , Levetiracetam , Midazolam , Uso Off-Label , Ondansetron , Cuidados Paliativos , Preparações Farmacêuticas
10.
Age Ageing ; 51(1)2022 01 06.
Artigo em Inglês | MEDLINE | ID: mdl-34794171

RESUMO

BACKGROUND: identifying drug-related hospital admissions (DRAs) in older people is difficult. A standardised chart review procedure has recently been developed. It includes an adjudication team (physician and pharmacist) screening using 26 triggers and then performing causality assessment to determine whether an adverse drug event (ADE) occurred (secondary to an adverse drug reaction, overuse, misuse or underuse) and whether the ADE contributed to hospital admission (DRA). OBJECTIVE: to assess the performance of those triggers in detecting DRA. DESIGN: retrospective study using data from the OPERAM (OPtimising thERapy to prevent Avoidable hospital admissions in Multimorbid older people) trial. SETTINGS: four European medical centres. SUBJECTS: multimorbid (≥ 3 chronic medical conditions) older (≥ 70 years) inpatients with polypharmacy (≥ 5 chronic medications) were enrolled in the OPERAM trial (N = 2,008) and followed for 12 months. We included patients with ≥1 adjudicated hospitalisation during the follow-up. METHODS: the positive predictive value (PPV; number of DRAs identified by trigger/number of triggers) was calculated for each trigger and for the tool as a whole. RESULTS: of 1,235 hospitalisations adjudicated for 832 patients, 716 (58%) had at least one trigger; an ADE was identified in 673 (54%) and 518 (42%) were adjudicated as DRAs. The overall PPV of the trigger tool for detecting DRAs was 0.66 [0.62-0.69]. CONCLUSIONS: this tool performs well for identifying DRAs in older people. Based on our results, a revised version of the tool was proposed but will require external validation before it can be incorporated into research and clinical practice.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Preparações Farmacêuticas , Idoso , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Hospitalização , Hospitais , Humanos , Polimedicação , Estudos Retrospectivos
11.
BMJ Open ; 11(7): e052755, 2021 07 14.
Artigo em Inglês | MEDLINE | ID: mdl-34261693

RESUMO

OBJECTIVES: The present study analysed 4 years of a hospital register (2015-2018) to determine the risk of 30-day hospital readmission associated with the medical conditions and drug regimens of polymedicated, older inpatients discharged home. DESIGN: Registry-based cohort study. SETTING: Valais Hospital-a public general hospital centre in the French-speaking part of Switzerland. PARTICIPANTS: We explored the electronic records of 20 422 inpatient stays by polymedicated, home-dwelling older adults held in the hospital's patient register. We identified 13 802 hospital readmissions involving 8878 separate patients over 64 years old. OUTCOME MEASURES: Sociodemographic characteristics, medical conditions and drug regimen data associated with risk of readmission within 30 days of discharge. RESULTS: The overall 30-day hospital readmission rate was 7.8%. Adjusted multivariate analyses revealed increased risk of hospital readmission for patients with longer hospital length of stay (OR=1.014 per additional day; 95% CI 1.006 to 1.021), impaired mobility (OR=1.218; 95% CI 1.039 to 1.427), multimorbidity (OR=1.419 per additional International Classification of Diseases, 10th Revision condition; 95% CI 1.282 to 1.572), tumorous disease (OR=2.538; 95% CI 2.089 to 3.082), polypharmacy (OR=1.043 per additional drug prescribed; 95% CI 1.028 to 1.058), and certain specific drugs, including antiemetics and antinauseants (OR=3.216 per additional drug unit taken; 95% CI 1.842 to 5.617), antihypertensives (OR=1.771; 95% CI 1.287 to 2.438), drugs for functional gastrointestinal disorders (OR=1.424; 95% CI 1.166 to 1.739), systemic hormonal preparations (OR=1.207; 95% CI 1.052 to 1.385) and vitamins (OR=1.201; 95% CI 1.049 to 1.374), as well as concurrent use of beta-blocking agents and drugs for acid-related disorders (OR=1.367; 95% CI 1.046 to 1.788). CONCLUSIONS: Thirty-day hospital readmission risk was associated with longer hospital length of stay, health disorders, polypharmacy and drug regimens. The drug regimen patterns increasing the risk of hospital readmission were very heterogeneous. Further research is needed to explore hospital readmissions caused solely by specific drugs and drug-drug interactions.


Assuntos
Readmissão do Paciente , Preparações Farmacêuticas , Idoso , Estudos de Coortes , Hospitais , Humanos , Pacientes Internados , Pessoa de Meia-Idade , Alta do Paciente , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Suíça/epidemiologia
12.
Int J Clin Pharm ; 40(2): 325-334, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-29322475

RESUMO

Introduction While drug-related problems (DRPs) in the inpatient setting are well known, the scope of these problems in home care has not been critically evaluated. Aim of the Review Our primary objective was to evaluate the incidence and demographics of DRPs in home care. Our specific aims were to characterize the rate of potentially inappropriate medications (PIMs), medication errors (MEs) and adverse drug events (ADEs) and to identify risk factors which contribute to DRPs in the home care setting. Methods Pubmed, Embase and CiNAHL databases were systematically searched from January 2000 to December 2016 for all publications which quantitatively characterized DRPs in the home care setting. Results The most commonly reported DRPs characterized in studies were PIMs (n = 16), MEs (n = 4) and the ME-subcategory medication-related discrepancies (n = 7). The frequency of PIMs ranged from 19.8 to 48.4%; up to 26% PIMs were considered severe. Polypharmacy (≥ 9 drugs) and increasing age were the most common risk factors for DRPs. Insufficient interdisciplinary teamwork and inconsistent performance of medication reviews were also risks factors for DRPs. Patients and/or caregivers were responsible for 42.3% of DRPs. Discussion Compared with acute inpatient care, DRPs are more frequently reported in home care. The rate of DRPs varies depending upon the reference used to define the problem. Conclusion Transfer of complete medical records and the use of an interdisciplinary team have the potential to reduce DRPs, including MEs, specifically when integrating a pharmacist providing regular medication review. Importantly, patients and informal caregivers must be significant partners with this interdisciplinary team.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Serviços de Assistência Domiciliar/normas , Prescrição Inadequada/prevenção & controle , Reconciliação de Medicamentos/normas , Polimedicação , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Humanos , Reconciliação de Medicamentos/métodos , Estudos Observacionais como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos
13.
Clin Ther ; 31(1): 32-41, 2009 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-19243705

RESUMO

BACKGROUND: Topical thrombins are active hemostatic agents that can be used to minimize blood loss during surgery. Before 2007, the only topical thrombins available were derived from bovine plasma. Antibody formation to bovine thrombin and/or factor V, with subsequent risk of cross-reactivity with human factor V, and hemorrhagic complications associated with human factor-V deficiencies have been described in case reports of surgeries in which bovine thrombins were used. This risk is now included in the boxed warning section of the bovine thrombin prescribing information. In 2007 and 2008, 2 new topical thrombins from nonbovine sources received approval for use from the US Food and Drug Administration. The 3 active topical thrombins that are currently marketed are bovine plasma-derived thrombin, human plasma-derived thrombin, and human recombinant thrombin. OBJECTIVE: The purpose of this review was to evaluate the literature on the efficacy and safety of topical thrombins and discuss the pharmacoeconomic considerations associated with their use. METHODS: PubMed, EMBASE, and International Pharmaceutical Abstracts were searched for relevant papers published in English through October 10,2008, using the terms thrombin, human recombinant thrombin, bovine thrombin, plasma derived thrombin, and topical thrombin. Manufacturer-provided materials were also reviewed. Abstracts and unpublished data, as well as evaluations of sealants, adhesives, glues, and other hemostats that contain thrombin mixed with fibrinogen and other clotting factors, were excluded. RESULTS: Four randomized, double-blind studies involving the active, stand-alone topical thrombins were found. The bovine thrombin involved in these studies was the predecessor to the currently marketed, highly purified bovine formulation. No studies comparing the human products, studies involving the highly purified bovine preparation, or placebo-controlled studies involving bovine thrombin were found. In a Phase III comparison of human recombinant thrombin and bovine thrombin, the percentages of patients who achieved hemostasis within 10 minutes of topical thrombin application were 95.4% and 95.1%, respectively (95% CI, -3.7 to 5.0). The incidence of hemostasis within 10 minutes was also similar in a Phase III comparison of human plasma-derived thrombin and bovine thrombin (both, 97.4% [95% CI, 0.96 to 1.05]). In the study that compared human recombinant and bovine thrombin, the incidence of antiproduct antibody formation was 21.5% (43/200) in the bovine thrombin group and 1.5% (3/198) in the human recombinant thrombin group (P < 0.001); patients with antibodies to bovine thrombin had numerically higher incidences of bleeding or thromboembolic events than did patients without these antibodies (19% vs 13%; P value not reported). Human plasma-derived thrombin is available as a frozen sterile solution that must be thawed before application, whereas the human recombinant and bovine plasma-derived products are supplied as unrefrigerated sterile powders that must be reconstituted before use. The human thrombins are more costly than bovine thrombin on a per-vial basis. The average wholesale prices (US $, 2008) for 5000-IU vials of bovine thrombin and human recombinant thrombin were $87.85 and $103.20, respectively; the average wholesale price for a 4000- to 6000-IU vial of human plasma-derived thrombin was $96.00. CONCLUSIONS: Topical thrombins vary in the ways in which they are manufactured and their safety profiles, storage requirements, and costs. Human recombinant thrombin and human plasma-derived thrombin have each been shown to have hemostatic efficacy comparable to that of bovine thrombin. Bovine thrombin carries the risk of formation of cross-reactive antibodies to bovine thrombin, factor V, and other impurities that may be present in these formulations. Immunogenicity data for the currently marketed, highly purified bovine thrombin relative to older formulations of bovine thrombin could not be found. Whether the potential safety advantage justifies the added cost of the human products remains to be established.


Assuntos
Hemostasia Cirúrgica/métodos , Hemostáticos/uso terapêutico , Proteínas Recombinantes/uso terapêutico , Trombina/uso terapêutico , Administração Tópica , Animais , Bovinos , Custos de Medicamentos , Hemostáticos/efeitos adversos , Hemostáticos/economia , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Proteínas Recombinantes/efeitos adversos , Proteínas Recombinantes/economia , Trombina/efeitos adversos , Trombina/economia , Estados Unidos
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA