Fernando Fernandez-Llimos

A systematic review of implementation frameworks of innovations in healthcare and resulting generic implementation framework

BackgroundImplementation science and knowledge translation have developed across multiple disciplines with the common aim of bringing innovations to practice. Numerous implementation frameworks, models, and theories have been developed to target a diverse array of innovations. As such, it is plausible that not all frameworks include the full range of concepts now thought to be involved in implementation. Users face the decision of selecting a single or combining multiple implementation frameworks. To aid this decision, the aim of this review was to assess the comprehensiveness of existing frameworks.MethodsA systematic search was undertaken in PubMed to identify implementation frameworks of innovations in healthcare published from 2004 to May 2013. Additionally, titles and abstracts from Implementation Science journal and references from identified papers were reviewed. The orientation, type, and presence of stages and domains, along with the degree of inclusion and depth of analysis of factors, strategies, and evaluations of implementation of included frameworks were analysed.ResultsFrameworks were assessed individually and grouped according to their targeted innovation. Frameworks for particular innovations had similar settings, end-users, and ‘type’ (descriptive, prescriptive, explanatory, or predictive). On the whole, frameworks were descriptive and explanatory more often than prescriptive and predictive. A small number of the reviewed frameworks covered an implementation concept(s) in detail, however, overall, there was limited degree and depth of analysis of implementation concepts. The core implementation concepts across the frameworks were collated to form a Generic Implementation Framework, which includes the process of implementation (often portrayed as a series of stages and/or steps), the innovation to be implemented, the context in which the implementation is to occur (divided into a range of domains), and influencing factors, strategies, and evaluations.ConclusionsThe selection of implementation framework(s) should be based not solely on the healthcare innovation to be implemented, but include other aspects of the framework’s orientation, e.g., the setting and end-user, as well as the degree of inclusion and depth of analysis of the implementation concepts. The resulting generic structure provides researchers, policy-makers, health administrators, and practitioners a base that can be used as guidance for their implementation efforts.

Translation and validation into portuguese Language of the Medication Regimen Complexity Index

BACKGROUND The complexity of pharmacotherapy is a result of a multiplicity of prescribed regimen factors, including the number of different drugs in the regimen, the number of dosage units per dose, the total number of prescribed doses per day and administration instructions. The Medication Regimen Complexity Index (MRCI) is a specific, reliable and valid tool used to measure the complexity of pharmacotherapy, originally developed in English language. OBJECTIVE Transcultural translation and validation of this tool into Brazilian Portuguese. METHODS A cross-sectional study was developed with 95 type-2 diabetes patients, receiving multiple medications. The validation process included translation into Portuguese, back-translation and pre-test of the tool, creating a new version called the Pharmacotherapy Complexity Index (PCI). The psychometric parameters were assessed, including convergent validity, discriminant validity and reliability (interclass and test-retest correlation). RESULTS The complexity of pharmacotherapy measured by the MRCI-Brazil had an average score of 15.7 points (SD=8.36). MRCI-Brazil showed significant correlation with the number of medications (r=0.86; p<0.001) and age of patients (r=0.28, p=0.005). Interrater reliability analysis found an intra-class correlation (ICC) of 0.99 (p<0.001) and test-retest correlation was of 0.997 (p<0.001). CONCLUSION The results have shown that the Brazilian version of the MRCI presents adequate validity and reliability, and may be useful in clinical practice and research involving the analysis of the drug regimen complexity.

Barreras para la implantación de servicios cognitivos en la farmacia comunitaria española

Objetivo Identificar y analizar los elementos que dificultan la diseminacion, la implantacion y la sostenibilidad de distintos servicios cognitivos orientados a los pacientes en la farmacia comunitaria espanola. Diseno Estudio cualitativo en el que se han utilizado entrevistas semiestructuradas, con el fin de realizar un analisis descriptivo. Metodos Se eligieron dos conjuntos de expertos relacionados con la farmacia comunitaria espanola. El primero estaba compuesto de 15 farmaceuticos comunitarios que se habian destacado por sus actividades profesionales y el segundo, por 18 estrategas de la farmacia. Resultados La falta de orientacion clinica de la formacion universitaria, la falta de actitud ante el cambio y la incertidumbre sobre su futuro profesional se identificaron como barreras del farmaceutico individual. Para la farmacia como empresa, se identificaron como barreras la falta de pago por los servicios, la ausencia de mensajes claros y el reducido volumen de la farmacia espanola. En la categoria profesion farmaceutica, el actual sistema de remuneracion, la falta de formacion universitaria clinica y la falta de liderazgo de las instituciones representantes fueron las barreras encontradas. En cuanto a los otros colectivos, se encontro que la falta de apoyo real de las administraciones sanitarias, el desconocimiento de los medicos de los objetivos de los servicios cognitivos farmaceuticos, y la falta de demanda de estos servicios por los pacientes fueron las barreras identificadas. Conclusiones Se han encontrado 12 barreras que se han agrupado en 6 categorias. Estas barreras coinciden con las comunicadas en otros paises.

Providing Patient Care in Community Pharmacies in Spain

OBJECTIVE To review the current status of Spanish community pharmacy, both in practice and research terms, and analyze its future trends. FINDINGS Spain has a social security system where all citizens receive health care, social services, and pensions. All medical care and surgery are free for citizens; however, community pharmacies in Spain are privately owned. There are geographic and population standards for the establishment of new pharmacies, resulting in an average of 1 pharmacy per 2000 residents. Almost all pharmacies offer the same services: compounding, weight and blood pressure measurement, and cholesterol and glucose testing. There are also other, less-implemented services, such as methadone supply or directed observed treatments. Most of these services are freely provided, except compounding (fee for service), methadone, and directed observed treatments. University pharmacy practice departments do not exist in Spain, which leads to scarce research in this area. DISCUSSION Efforts have been made to describe and measure the prevalence of negative clinical outcomes produced by pharmacotherapy and create an operational procedure to provide pharmacotherapy follow-up. CONCLUSIONS Spain has many community pharmacies, but there is little pharmacy practice research. Some advanced cognitive services exist, but few are being remunerated.

Effectiveness of clinical pharmacy services: an overview of systematic reviews (2000–2010)

Background Multiple reviews have evaluated the impact of pharmacist-delivered patient care on health-related outcomes. However, it is unclear which of the pharmacist-delivered interventions in these services are the most effective. Aim of the review To gather the evidence of the impact of clinical pharmacy services on the medication use process or on patient outcomes using an overview of systematic reviews. Methods PubMed was searched to retrieve systematic reviews published between 2000 and 2010 that assessed the impact of clinical pharmacy services on the medication use process or patient outcomes. Two independent reviewers evaluated the study eligibility and one extracted the description and results of the services. The methodological quality of each review was assessed with the R-AMSTAR tool. Results Of the 343 potentially relevant records identified, 49 systematic reviews, comprising a total of 269 randomized controlled trials, met the selection criteria. Clinical pharmacy services that focused on specific medical conditions, such as hypertension or diabetes mellitus, revealed a positive impact of pharmacists’ interventions on patient outcomes. For other medical conditions, however, the results were inconclusive (e.g., dyslipidemia or thromboprophylaxis). Interventions that targeted medication adherence and assessed the impact of clinical pharmacy services in prescription appropriateness also produced inconclusive results because of the variability of methods used to assess both medication adherence and medication appropriateness. Conclusions Systematic reviews that assessed clinical pharmacy services targeting specific conditions were more conclusive given that the intervention was well defined, and the measured outcomes were unequivocal and tangible. Conversely, the results were inconclusive for interventions with a broader target and with monitoring parameters that were unclearly established or inconsistently assessed across studies. These findings emphasize the need to better define clinical pharmacy services and standardize methods that assess the impact of these services on patient health outcomes.

Antidepressant utilization in primary care in a Spanish region: impact of generic and reference-based pricing policy (2000-2004).

ObjectiveTo describe the evolution of antidepressant use in primary care in the Valencian region (Spain) from 2000 to 2004 and to analyze the effects of reference-based price and generic drugs introduction on drug utilization and cost saving.MethodsRetrospective observational study in primary care using sales data collected from antidepressant group (N06A), corresponding to the period 2000–2004. Defined daily dose (DDD)/1000 inhabitants per day were obtained as consumption data. Cost and cost/DDD rate evolution was related to reference price system implantation.ResultsAntidepressant utilization progressively increased by 44.0% from 30.3 DDDs/1000 per day in 2000 to 43.5% in 2004. Selective serotonin reuptake inhibitors (SSRIs) comprised 77% of the total consumption where paroxetine, sertraline and fluoxetine were the most used drugs in 2004. The proportion of relative use and cost of fluoxetine declined after a reference price and the introduction of generic competitors were put into effect in 1999; cost/DDD was reduced by 1.8. Third-generation antidepressants showed a fast rising rate i.e. venlafaxine utilization multiplied by 2.2; this drug with the higher cost/DDD was not subjected to the reference price system. Reduction in citalopram utilization was related to a replacement by its recently marketed enantiomer escitalopram.ConclusionsIn 2004, reference price policy and the implementation of generic drugs reduced the antidepressant cost by DDD. However, antidepressant expenditure increased since 2000 due to a continued growth in consumption (SSRIs and novel agents) and a displacement of prescriptions to drugs that were not included in the reference price policy.

A Tool to Characterize the Components of Pharmacist Interventions in Clinical Pharmacy Services: The DEPICT Project

BACKGROUND The complexity of clinical pharmacy services usually leads to an inconsistent or even poor description of their interventions in scientific reports. To ensure comparability and reproducibility of the evidence, an in-depth description of pharmacist interventions is required. OBJECTIVE To validate a new tool called DEPICT (Descriptive Elements of Pharmacist Intervention Characterization Tool) to characterize clinical pharmacy services. METHODS We developed a 3-phase study. First, to create a theoretical framework, an overview of systematic reviews was performed in PubMed between 2000 and 2010. Then, an in-depth analysis of the included studies was carried out to identify a list of components in order to create the instrument. Finally, 2 independent raters separately applied the tool to a random sample of 28 randomized clinical trials extracted from the systematic reviews. Interrater agreement was evaluated using PABAK (prevalence-adjusted bias-adjusted κ) coefficient or intraclass correlation coefficient (ICC). RESULTS We included 49 systematic reviews in our overview. Analysis of these studies resulted in 58 intervention components, with 57 dichotomous variables and 1 discrete variable. These items resulted in a preliminary version of the instrument. The reliability analysis showed that 8 binary items of this version had a PABAK less than or equal to 0.60. These items were then excluded or modified, resulting in a final version of the tool, with 54 items organized into 12 domains. DEPICT showed an average PABAK of 0.85 (95% CI 0.81 to 0.88) and an ICC of 1.0. Twenty items presented a PABAK value between 0.61 and 0.80 (substantial agreement) and 33 had a value between 0.81 and 1.0 (almost perfect agreement). CONCLUSIONS DEPICT is a reproducible instrument for describing the components of pharmacist interventions performed as part of clinical pharmacy services. It allows retrospective analysis of published studies and can be used as a reference guide to report pharmacist interventions in future studies.

Evaluation of the Pharmacy Safety Climate Questionnaire in European community pharmacies

OBJECTIVE To evaluate the internal reliability, factor structure and construct validity of the Pharmacy Safety Climate Questionnaire (PSCQ) when applied to a pan-European sample of community pharmacies. DESIGN A cross-sectional survey design was used. SETTING Community pharmacies in Denmark, Germany, the Netherlands, Portugal and Great Britain. PARTICIPANTS A total of 4105 members of the community pharmacy workforce, all drawn from one of the five participating countries. MAIN OUTCOME MEASURES Each participant completed a copy of the Pharmacy Safety Climate Questionnaire in his or her respective language and rated the perceived safety of the pharmacy in which he or she worked. RESULTS Exploratory and confirmatory factor analyses of the data identified four factors that accounted for item responses, with 24 of the original 34 items loading onto them. They were labelled organizational learning, blame culture, working conditions and safety focus. These factors were found to have an acceptable level of reliability (with Cronbachs alpha values ranging from 0.70 to 0.92) and to predict the rating of pharmacy safety. CONCLUSIONS This study provided information on the PSCQs psychometric properties when used in community pharmacies in different European countries. A modified version of the original PSCQ (known as PSCQ-4) is presented, and further work is proposed to demonstrate its application to safety improvements in pharmacies.

Perfil dos farmacêuticos e farmácias em Santa Catarina: indicadores de estrutura e processo

The present study aimed to assess structure and process quality indicators in community pharmacies in Santa Catarina (Brazil), and also the profile of pharmacists regarding their attitudes and perceptions of pharmaceutical care and professional satisfaction. A cross-sectional study was performed in 10% of Santa Catarina pharmacies randomly chosen. 258 community pharmacies were surveyed. 88.5% pharmacists were in office in the time of the interview. In average, they were 31 years old (SD=8.1) and mainly women (68%). A ratio of 1.4 (SD=0.7) pharmacists per pharmacy and 3.8 (SD=4.5) assistants existed. Only 11.4% pharmacies had an adequate structure for private caring patients. Despite having an average of more than 2 tertiary drug information sources, most of them were low quality. Activities mentioned by the majority of pharmacists were dispensing (98.2%), recording controlled drugs (90.8%), injections administration (85.1%), and helping patients on cash line (84.2%). Most of pharmacies in Santa Catarina (Brazil) do not have the adequate structure for implementing pharmaceutical care services. Barriers identified to implement those services were not different to those communicated in other countries.

Clinical Pharmacology Information in Summaries of Product Characteristics and Package Inserts

The aim of the study was to assess the clinical pharmacology information provided in the summaries of product characteristics (SPCs) of European drugs compared with their package inserts. A list of the 150 most prescribed drugs at the local Health Service was assessed. To analyze clinical pharmacology information contained in package inserts and SPCs, Spykers systematized scoring approach was used (scoring from 0 to 2). Ninety‐one SPCs (84.3%) and 108 package inserts were obtained. The mean score for core information provided in the package inserts was 7.94 (confidence interval (CI) 95%: 7.34–8.53), whereas for the SPCs it was 17.62 (CI 95%: 16.48–18.75; 35.2% of the maximum). One core information item and two extra credit items were not contained in any of the SPCs. In the European Union the clinical pharmacology information found in SPCs is clearly insufficient. An improved access to and regular review of the SPCs might substantially improve the access and quality of clinical pharmacology and other prescribing information.