[Variability in Drug Procurement within Group 1B of the Pharmaceutical Specialized Scheme in Brazil]. / Variabilidade de preços de aquisição de medicamentos do grupo 1B do Componente Especializado da Assistência Farmacêutica.

In the Brazilian Health System (SUS), drugs covered by the Specialized Pharmaceutical Scheme (CEAF) receive federal funding and can be procured either centrally (Group 1A) or by individual states (Federal Units - UF) (Group 1B). Unlike other countries where national procurement prices are negotiated centrally by the government, public procurement in Brazil follows a public auction procedure, potentially resulting in varying purchase prices. To facilitate price comparisons, it is a legal requirement to register public acquisitions in the Health Prices Registry (BPS). This study aimed to assess the variability in the procurement prices for Group 1B drugs across the 27 Brazilian states during 2021. Data on the acquisitions of Group 1B drugs by the 27 Health Secretariats were obtained from the BPS. Drugs with no reported reimbursement prices as of December 2021 were excluded from the analysis. The total reimbursement amount for each state was sourced from the SUS Ambulatory Information System. The findings revealed significant variability in drug procurement prices both across and within states. The study underscored a potential disparity in CEAF access, favoring wealthier states (those with larger populations and higher economic status) by securing lower drug prices.

No Sistema Único de Saúde os medicamentos do grupo 1 do Componente Especializado da Assistência Farmacêutica (CEAF) são financiados pela União e adquiridos de forma centralizada (grupo 1A) ou por cada Unidade Federativa (UF) (grupo 1B). Diferentemente de outros países onde se negocia um preço fixo a ser praticado no sistema público, no Brasil as aquisições são realizadas por licitação, o que pode levar a diferentes preços. Para permitir a comparação de preços, foi pactuada a obrigatoriedade de registro das aquisições públicas no Banco de Preços em Saúde (BPS). O estudo teve como objetivo analisar a variabilidade dos preços de medicamentos do grupo 1B adquiridos pelas UF do Brasil em 2021. Foram obtidas as aquisições de medicamentos do grupo 1B realizadas pelas Secretarias de Estado das 27 UF por consulta ao BPS excluindo-se os medicamentos sem preço de ressarcimento estabelecido em dezembro/2021. Foi obtido do Sistema de Informações Ambulatoriais o ressarcimento para cada UF. Verificou-se grande variabilidade dos preços de aquisição para cada medicamento entre as UF e dentro da mesma UF. O estudo demonstrou potencial iniquidade de acesso ao CEAF, privilegiando com menores preços UF mais favorecidas (maior população e riqueza).

Variabilidade de preços de aquisição de medicamentos do grupo 1B do Componente Especializado da Assistência Farmacêutica / Variability in Drug Procurement within Group 1B of the Pharmaceutical Specialized Scheme in Brazil

Resumo No Sistema Único de Saúde os medicamentos do grupo 1 do Componente Especializado da Assistência Farmacêutica (CEAF) são financiados pela União e adquiridos de forma centralizada (grupo 1A) ou por cada Unidade Federativa (UF) (grupo 1B). Diferentemente de outros países onde se negocia um preço fixo a ser praticado no sistema público, no Brasil as aquisições são realizadas por licitação, o que pode levar a diferentes preços. Para permitir a comparação de preços, foi pactuada a obrigatoriedade de registro das aquisições públicas no Banco de Preços em Saúde (BPS). O estudo teve como objetivo analisar a variabilidade dos preços de medicamentos do grupo 1B adquiridos pelas UF do Brasil em 2021. Foram obtidas as aquisições de medicamentos do grupo 1B realizadas pelas Secretarias de Estado das 27 UF por consulta ao BPS excluindo-se os medicamentos sem preço de ressarcimento estabelecido em dezembro/2021. Foi obtido do Sistema de Informações Ambulatoriais o ressarcimento para cada UF. Verificou-se grande variabilidade dos preços de aquisição para cada medicamento entre as UF e dentro da mesma UF. O estudo demonstrou potencial iniquidade de acesso ao CEAF, privilegiando com menores preços UF mais favorecidas (maior população e riqueza).

Abstract In the Brazilian Health System (SUS), drugs covered by the Specialized Pharmaceutical Scheme (CEAF) receive federal funding and can be procured either centrally (Group 1A) or by individual states (Federal Units - UF) (Group 1B). Unlike other countries where national procurement prices are negotiated centrally by the government, public procurement in Brazil follows a public auction procedure, potentially resulting in varying purchase prices. To facilitate price comparisons, it is a legal requirement to register public acquisitions in the Health Prices Registry (BPS). This study aimed to assess the variability in the procurement prices for Group 1B drugs across the 27 Brazilian states during 2021. Data on the acquisitions of Group 1B drugs by the 27 Health Secretariats were obtained from the BPS. Drugs with no reported reimbursement prices as of December 2021 were excluded from the analysis. The total reimbursement amount for each state was sourced from the SUS Ambulatory Information System. The findings revealed significant variability in drug procurement prices both across and within states. The study underscored a potential disparity in CEAF access, favoring wealthier states (those with larger populations and higher economic status) by securing lower drug prices.

Principles of pharmacoeconomic analysis: the case of pharmacist-led interventions.

In the past years, several factors such as evidence-based healthcare culture, quality-linked incentives, and patient-centered actions, associated with an important increase of financial constraints and pressures on healthcare budgets, resulted in a growing interest by policy-makers in enlarging pharmacists' roles in care. Numerous studies have demonstrated positive therapeutic outcomes associated with pharmaceutical services in a wide array of diseases. Yet, the evidence of the economic impact of the pharmacist in decreasing total health expenditures, unnecessary care, and societal costs relies on well-performed, reliable, and transparent economic evaluations, which are scarce. Pharmacoeconomics is a branch of health economics that usually focuses on balancing the costs and benefits of an intervention towards the use of limited resources, aiming at maximizing value to patients, healthcare payers and society through data driven decision making. These decisions can be guide by a health technology assessment (HTA) process that inform governmental players about medical, social, and economic implications of development, diffusion, and use of health technologies - including clinical pharmacy interventions. This paper aims to provide an overview of the important concepts in costing in healthcare, including studies classification according to the type of analysis method (e.g. budget-impact analysis, cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis), types of costs (e.g. direct, indirect and intangible costs) and outcomes (e.g. events prevented, quality adjusted life year - QALY, disability adjusted life year - DALY). Other key components of an economic evaluation such as the models' perspective, time horizon, modelling approaches (e.g. decision trees or simulation models as the Markov model) and sensitivity analysis are also briefly covered. Finally, we discuss the methodological issues for the identification, measurement and valuation of costs and benefits of pharmacy services, and suggest some recommendations for future studies, including the use of Value of Assessment Frameworks.

Efficacy and safety of oral phosphodiesterase 5 inhibitors for erectile dysfunction: a network meta-analysis and multicriteria decision analysis.

PURPOSE: To quantitatively assess the benefit-risk ratio on the efficacy and safety of all phosphodiesterase type 5 inhibitors (PDE5i) in men with erectile dysfunction. METHODS: A systematic review with network meta-analysis, surface under the cumulative ranking analysis and stochastic multicriteria acceptability analyses were performed. Searches were conducted in Pubmed, Scopus, Web of Science without limits for time-frame or language. Randomized controlled trials evaluating the efficacy or safety of any PDE5i compared to a placebo or to other PDE5i in males with erectile disfunction were included. RESULTS: Overall, 184 articles representing 179 randomized controlled trials (50,620 patients) were included. All PDE5i were significantly more efficient than placebo. Sildenafil 25 mg was statistically superior to all interventions in enhancing IIEF (with a 98% probability of being the most effective treatment), followed by sildenafil 50 mg (80% of probability). Taladafil 10 mg and 20 mg also presented good profiles (73% and 76%, respectively). Avanafil and lodenafil were less effective interventions. Mirodenafil 150 mg was the treatment that caused more adverse events, especially flushing and headaches. Sildenafil 100 mg was more related to visual disorders, while vardenafil and udenafil were more prone to cause nasal congestion. CONCLUSION: Sildenafil at low doses and tadalafil should be the first therapeutic options. Avanafil, lodenafil and mirodenafil use are hardly justified given the lack of expressive efficacy or high rates of adverse events.

Safety outcomes of disease-modifying therapies for relapsing-remitting multiple sclerosis: A network meta-analysis.

BACKGROUND: Randomised clinical trials (RCTs) and observational studies have reported adverse events that preclude the use of disease-modifying therapies (DMTs) in relapsing-remitting multiple sclerosis (RRMS) in the long term or in specific populations, however, little is known about the relationship between the use of DMTs and frequency of undesirable events. We aimed to conduct a systematic review and network meta-analyses (NMAs) of RCTs and observational studies to synthesise the evidence on the safety of all available DMTs for patients with RRMS. METHODS: PubMed, Scopus and a manual search were performed. Bayesian NMAs of safety outcomes reported in RCTs and observational studies assessing DMTs as monotherapies were conducted. RESULTS: Forty-seven studies were included in the systematic review. Considering all studies, 368 and 149 different safety outcomes were reported for at least one study and two studies, respectively. Considering clinical trials, 22 NMAs were conducted for 16 outcomes. Regarding geometry metrics, the median number of studies, DMTs, common comparator, strong edge, and patients were 5 (IQR 5-9), 5 (IQR 4-8), 44%, 33%, and 3998 (IQR 3380-6761). In summary, most comparisons showed similar risk of safety events for DMTs and placebo for all outcomes. Considering cohort studies, only three meta-analyses were conducted. CONCLUSION: Safety outcomes are poorly reported in primary studies of DMTs in RRMS, precluding the conduction of robust meta-analyses. Therefore, the current available data on safety of these drugs is not contributing to regulatory and clinical decision making, with adverse event reports underbalanced compared to efficacy outcomes.

Inovação em serviços farmacêuticos clínicos no componente especializado da assistência farmacêutica do Estado do Paraná / Innovating in clinical pharmacy services at the specialized component of pharmaceutical management in the state of Paraná

A implementação de serviços farmacêuticos clínicos, seja em âmbito público ou privado, não tem alcançado os níveis desejados. Uma das explicações para esse fato pode residir no desenho desses serviços que por vezes são serviços amplos, complexos e com objetivos demasiado ambiciosos. A partir de processos de reengineering, uma carteira de serviços farmacêuticos clínicos no âmbito do Componente Especializado da Assistência Farmacêutica (CEAF) da Secretaria de Estado da Saúde do Paraná (SES/PR), está sendo desenhada com intuito de melhorar os desfechos clínicos resultantes do uso de medicamentos desse componente. A proposta é implementar vários serviços com objetivos específicos utilizando a seleção de pacientes guiada por dados (data driven). Implementar esses serviços e torná-los sustentáveis é o desafio que se apresenta à Assistência Farmacêutica da SES/PR para os próximos anos com o objetivo de contribuir para melhoria da saúde dos pacientes e para a racionalização de recursos do sistema de saúde. (AU)

Clinical pharmacy services implementation, either in public or private sectors, has not reached desirable levels. A potential explanation for this poor implementation may be a poor service design, which is frequently too comprehensive and complex, with too ambitious objectives. By using reengineering processes, the Specialized Component of the Public Pharmaceutical Management (CEAF) of the State Secretary of Health (SES/PR) in the state of Paraná, a portfolio of clinical pharmacy services, is being designed to improve patients' clinical outcomes resulting from the use of the medicines from this component. The concept is based on the creation of several different services with specific objectives using a data-driven patient selection process. Implementing these services and making them sustainable is the challenge that CEAF will face at SES/PR in the following years, aiming at improving individuals' health and rationalizing public Health System resources. (AU)

An evidence-based model to consolidate medication adherence cost estimation: the medication adherence cost estimation framework.

Aim: To develop a standardized framework determining the economic impact of medication nonadherence. Materials & methods: Secondary analysis of existing literature reported cost data, aggregating cost outcome indicators. Weighted-average cost analysis performed, determining the proportional contribution to total cost. Results: Direct costs were reported in 92% of studies and indirect costs in 4% of studies. Three most utilized cost categories were hospital (68%), primary care (18%) and pharmacy costs (72%). Average unadjusted direct costs ranged from $625 to $154,203 contributing to 88% of the total cost; adjusted medical costs ranged from $565 to $56,313 representing 96% of the total cost. Conclusion: The medication adherence cost estimation framework enables the comparison of costing studies, facilitating informed health policy decision-making based on consistent evidence and terminology.

Usability and sensitivity of the risk of bias assessment tool for randomized controlled trials of pharmacist interventions.

Background The Cochrane collaboration risk of bias assessment (RoB) tool is used in several fields to evaluate the methodological quality of studies. Its strengths and challenges are discussed. Objective To assess the sensitivity of the RoB tool in studies of pharmacist interventions. Setting DEPICT database was used to pool randomized controlled trials (RCTs) of complex interventions. Method A Guide for RoB Judgment in Pharmacy Services was created to help in the interpretation and judgment of bias criteria. The evaluation of bias (low, unclear, high risk) was performed by RCT. Sensitivity analyses were performed to assess the influence of different interpretations of eight elements of judgment in the RoB tool. Paired analysis and estimations of the effect size (95% confidence interval) of the criteria modifications compared to the original analyses were calculated. Main outcome measure Changes in the interpretations of judgment in the RoB tool. Results Overall, 8.3, 45.4, and 46.3% of the studies were determined to have low, unclear, and high risk of bias, respectively. High risk of bias was caused by attrition and detection domains. The number of studies classified with high risk of bias significantly increased for five of the eight interpretations, while unclear risk of bias increased for three interpretations (with a negligible effect size in all of them). Lack of blinding, loss of participants, and the use of subjective and self-reported outcomes were the main elements resulting in high risk of bias. Conclusion The RoB tool is useful for evaluating RCTs of pharmacist interventions if adapted criteria for judgment are used. Ignoring these adjustments produces a floor-effect with studies classified with high risk of bias.

A model for the financial assessment of professional services in community pharmacy: A systematic review.

OBJECTIVES: Limited studies have assessed the financial benefit of professional pharmacy services (PPSs) to the community pharmacy as a business. These studies are crucial in developing an insight into the long-term sustainability and broader implementation of services. We reviewed the literature to identify measures and indicators used to assess the financial performance of professional services in community pharmacy. DATA SOURCES: The literature search was undertaken in Pubmed and Scopus, and a gray literature search was performed in Google.com. References of the included papers were reviewed for other relevant studies. STUDY SELECTION: Articles were reviewed against the following exclusion criteria: 1) literature reviews, 2) studies not reporting quantitative financial data from community pharmacy, 3) studies not assessing a PPS, 4) studies lacking a methodology for the measurement and assessment of financial outcomes, and 5) cost-effectiveness analysis, cost-utility analysis, or cost-benefit analysis studies. DATA EXTRACTION: A piloted data extraction form was used. A selection of key data collected is as follows: 1) method of data collection and calculation, 2) currency, limitations for cost and revenue and method of data collection and method of calculation, 3) standardized currency value for the results reported, 4) professional services: number assessed, type of service, name of services, nature of services, implementation stage reported, financial result, the frequency of service, costs, sources of revenue, net total cost, net total revenue, break-even point, break-even price, net profit and loss. RESULTS: The 21 studies included used different methodologies and indicators to financially assess PPSs. This has led to the development of a model for assessing PPSs composed of the key financial elements identified in this systematic review. CONCLUSION: From this review, we propose a model that provides a structured approach for pharmacists to manage the financial performance of services.

Methodological quality assessment of network meta-analysis of drug interventions: implications from a systematic review.

BACKGROUND: We aimed to determine the methodological quality of network meta-analyses (NMAs) and their compliance with reporting guidelines. METHODS: A systematic review of NMAs comparing any pharmacological interventions was performed (searches in Medline and Scopus). The characteristics of NMAs were collected by two independent reviewers. We applied R-AMSTAR to all NMAs, generating a methodological quality score that could range from 11 to 44 points. PRISMA and PRISMA-NMA reporting checklists were converted into quantitative scores (maximum values of 27 and 32 points). To normalize the values between these two checklists, a third score (PRISMA-SCORE) of 0-1 was created. The correlation of the scores with NMA publication year, journal impact factor and most productive countries were calculated using non-parametric tests. RESULTS: We identified 477 NMAs. Only 36.1% of studies reported having followed PRISMA statements. The medians of R-AMSTAR, PRISMA and PRISMA-NMA scores were 28 (IQR 25-31), 21 (IQR 19-23) and 23 (IQR 19-26), respectively. Several problems were noted in NMAs (e.g. lack of study protocol, issues in literature searches, lack of raw data). NMAs from the most productive countries (USA and China) have similar methodological quality. Correlation analyses between R-AMSTAR and normalized PRISMA-SCORE revealed a strong positive correlation (Spearman's ρ = 0.776; P <0.001). A weak but positive correlation was found for PRISMA-SCORE and journal impact factor (0.193; P <0.001). CONCLUSIONS: The important growth of NMA publication rate during the past 5 years is not associated with better methodological and reporting quality. Editors, peer reviewers, researchers and funding agencies should ensure that methodological and reporting standards are met before publication.

Comparative efficacy and safety of tyrosine kinase inhibitors for chronic myeloid leukaemia: A systematic review and network meta-analysis.

BACKGROUND: The pharmacotherapy of chronic myeloid leukaemia (CML) is mainly based on tyrosine kinase inhibitors (TKIs). The aim of this study was to compare the efficacy and safety of all TKIs in CML patients. METHODS: We conducted a systematic review with network meta-analysis (NMA) of randomised controlled trials (RCTs), including imatinib, nilotinib, dasatinib, bosutinib, radotinib and ponatinib. Searches were performed in PubMed, Scopus, Web of Science and SciELo (March 2018). The NMAs were built for six outcomes at 12 months: complete cytogenetic response (CCyR), major cytogenetic response (MCyR), deep molecular response, major molecular response (MMR), complete haematologic response and incidence of serious adverse events. We conducted rank order and surface under the cumulative ranking curve (SUCRA) analyses. RESULTS: Thirteen RCTs were included (n = 5079 patients). Statistical differences were observed for some comparisons in all outcomes. Imatinib 400 mg was considered the safest drug (SUCRA values of 10.3%) but presented low efficacy. Overall, nilotinib 600 mg was superior to the other TKI in efficacy (SUCRA values of 61.1% for CCyR, 81.0% for MMR, 90.0% for MCyR); however, no data on its safety profile at 12 months were reported. INTERPRETATION: Our results suggest that nilotinib should be upgraded to first-line therapy for CML, although further cost-effectiveness analyses, including the new TKI (i.e., ponatinib, radotinib), are needed.

Economic impact of medication non-adherence by disease groups: a systematic review.

OBJECTIVE: To determine the economic impact of medication non-adherence across multiple disease groups. DESIGN: Systematic review. EVIDENCE REVIEW: A comprehensive literature search was conducted in PubMed and Scopus in September 2017. Studies quantifying the cost of medication non-adherence in relation to economic impact were included. Relevant information was extracted and quality assessed using the Drummond checklist. RESULTS: Seventy-nine individual studies assessing the cost of medication non-adherence across 14 disease groups were included. Wide-scoping cost variations were reported, with lower levels of adherence generally associated with higher total costs. The annual adjusted disease-specific economic cost of non-adherence per person ranged from $949 to $44 190 (in 2015 US$). Costs attributed to 'all causes' non-adherence ranged from $5271 to $52 341. Medication possession ratio was the metric most used to calculate patient adherence, with varying cut-off points defining non-adherence. The main indicators used to measure the cost of non-adherence were total cost or total healthcare cost (83% of studies), pharmacy costs (70%), inpatient costs (46%), outpatient costs (50%), emergency department visit costs (27%), medical costs (29%) and hospitalisation costs (18%). Drummond quality assessment yielded 10 studies of high quality with all studies performing partial economic evaluations to varying extents. CONCLUSION: Medication non-adherence places a significant cost burden on healthcare systems. Current research assessing the economic impact of medication non-adherence is limited and of varying quality, failing to provide adaptable data to influence health policy. The correlation between increased non-adherence and higher disease prevalence should be used to inform policymakers to help circumvent avoidable costs to the healthcare system. Differences in methods make the comparison among studies challenging and an accurate estimation of true magnitude of the cost impossible. Standardisation of the metric measures used to estimate medication non-adherence and development of a streamlined approach to quantify costs is required. PROSPERO REGISTRATION NUMBER: CRD42015027338.

A modified Delphi study to determine the level of consensus across the European Union on the structures, processes and desired outcomes of the management of polypharmacy in older people.

BACKGROUND: Inappropriate use of multiple medicines (inappropriate polypharmacy) is a major challenge in older people with consequences of increased prevalence and severity of adverse drug reactions and interactions, and reduced medicines adherence. The aim of this study was to determine the levels of consensus amongst key stakeholders in the European Union (EU) in relation to aspects of the management of polypharmacy in older people. METHODS: Forty-six statements were developed on aspects of healthcare structures, processes and desired outcomes, with consensus defined at ≥ 80% agreement. Panel members were strategists (e.g. directors, leading clinicians and commissioners) from each of the 28 EU member states, with a target recruitment of five per member state. Three Delphi rounds were conducted via email, with panel members being provided with summative results and collated, anonymised comments at the commencement of Rounds 2 and 3. RESULTS: Ninety panel members were recruited (64.3% of target), with high participation levels throughout the three Delphi rounds (91.1%, 83.3%, 72.2%). During Round 1, consensus was obtained for 27/46 statements (58.7%), with an additional two statements in Round 2 and none in Round 3. Consensus was obtained for statements relating to: potential gain arising from polypharmacy management (3/4 statements); strategic development (7/7); change management (5/7) indicator measures (4/6); legislation (0/3); awareness raising (5/5); polypharmacy reviews (5/7); and EU vision (0/7). Analysis of free text comments indicated that the vision statements were too ambitious and not achievable by the specified timeframe of 2025. CONCLUSION: Consensus was obtained amongst key EU strategists around many aspects of polypharmacy management in older people. Notably, no consensus was achieved in relation to statements relating to the need to alter legislation in areas of healthcare delivery, remuneration and practitioner scope of practice. While the vision for the EU by 2025 was considered rather ambitious, there is great potential and clear opportunity to advance polypharmacy management throughout the EU and beyond.

Efficacy and safety of amphotericin B formulations: a network meta-analysis and a multicriteria decision analysis.

OBJECTIVES: Despite its broad spectrum, conventional amphotericin B (AB) is associated with serious adverse events. Lipid-based formulations may offer safer options. We aimed to synthesize the evidence of efficacy and safety of AB formulations. METHODS: We performed a systematic review and network meta-analysis (NMA) to compare all available formulations: conventional AB; lipid complex or ABLC; colloidal dispersion or ABCD; liposomal or LAB; AB in Intralipid. Randomized controlled trials were searched in four databases. Cure, fever, chills, nephrotoxicity, death and drug discontinuation were assessed. NMA was based on Bayesian methods accounting for direct and indirect comparisons. Probability ranks estimating the best formulation were built for each outcome. The relative benefit-risk of formulations was assessed with stochastic multicriteria acceptability analyses (SMAA). KEY FINDINGS: We identified 25 trials (n = 2996). No significant differences among drugs were observed for cure or death. All lipid-based formulations were safer than conventional AB for nephrotoxicity. AB-Intralipid was more tolerable than conventional AB and caused less chills than ABCD. AB-Intralipid was the best therapy (>60%) regarding nephrotoxicity, fever, chills and discontinuation. The scenario from SMAA favoured AB-Intralipid (81% acceptability). Conventional AB was secondary to all lipid-based formulations. CONCLUSIONS: Amphotericin B-Intralipid was identified as safer, cost-saving treatment in comparison with other formulations.

Best practice strategies to safeguard drug prescribing and drug administration: an anthology of expert views and opinions.

BACKGROUND: While evidence on implementation of medication safety strategies is increasing, reasons for selecting and relinquishing distinct strategies and details on implementation are typically not shared in published literature. OBJECTIVE: We aimed to collect and structure expert information resulting from implementing medication safety strategies to provide advice for decision-makers. SETTING: Medication safety experts with clinical expertise from thirteen hospitals throughout twelve European and North American countries shared their experience in workshop meetings, on-site-visits and remote structured interviews. METHODS: We performed an expert-based, in-depth assessment of implementation of best-practice strategies to improve drug prescribing and drug administration. MAIN OUTCOME MEASURES: Workflow, variability and recommended medication safety strategies in drug prescribing and drug administration processes. RESULTS: According to the experts, institutions chose strategies that targeted process steps known to be particularly error-prone in the respective setting. Often, the selection was channeled by local constraints such as the e-health equipment and critically modulated by national context factors. In our study, the experts favored electronic prescribing with clinical decision support and medication reconciliation as most promising interventions. They agreed that self-assessment and introduction of medication safety boards were crucial to satisfy the setting-specific differences and foster successful implementation. CONCLUSION: While general evidence for implementation of strategies to improve medication safety exists, successful selection and adaptation of a distinct strategy requires a thorough knowledge of the institute-specific constraints and an ongoing monitoring and adjustment of the implemented measures.

Differences in the information about procedures after cold chain disruption provided by pharmaceutical industry to hospital and community pharmacies.

PURPOSE: To compare the response of the pharmaceutical industry to information requests from a hospital pharmacy and a community pharmacy regarding the inadvertent exposure of refrigerated medicines (2-8°C) to out-of-range temperatures. METHODS: A complete list of all authorised medicines labelled for refrigeration was obtained from the Portuguese Medicines Agency. A standard information request regarding cold chain disruption for refrigerated medicines was sent to pharmaceutical companies from a hospital and a community pharmacy in Portugal. For companies who did not provide a response within the first 45 days, a second request was sent and an additional 45 days were allowed before completing data collection. To compare information received from the drug industry with that contained in the official European labelling, the Summaries of Product Characteristics (SmPCs) were retrieved from the regulatory agencies' databases. Response rate, response time and information appropriateness were assessed. RESULTS: A total of 792 medicines marketed by 70 different pharmaceutical companies were included. The hospital pharmacy received 560 (70.7%) responses, with a mean response time of 6.5 days (SD=5.3) for the first request. The community pharmacy obtained a response for 411 (51.9%), with a mean response time of 15.5 days (SD=4.8). More appropriate information was provided to hospital pharmacy requests. SmPCs did not contain complete information regarding the inadvertent exposure of medicines to unrefrigerated conditions. CONCLUSIONS: When enquired about a specific piece of information, the pharmaceutical industry provided quicker, higher quality and more frequent responses to a hospital pharmacy compared with a community pharmacy.

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.

Characterization of the Medical Subject Headings thesaurus for pharmacy.

PURPOSE: The completeness and utility of pharmacy-oriented Medical Subject Headings (MeSH) relative to MeSH terminology pertaining to other healthcare professions (dentistry and nursing) are evaluated. METHODS: The 2013 version of the MeSH thesaurus-the standard vocabulary used by the National Library of Medicine (NLM) to index articles in PubMed and MEDLINE-was searched for dentistry-, nursing-, and pharmacy-specific terms using a truncation strategy (search terms: nurs*, dent*, and pharm*); the hierarchical level of each term and the number of descendant terms (an indication of the granularity of the associated NLM-indexed content) were determined. PubMed searches were conducted to identify areas of the MeSH hierarchy containing dentistry- and nursing-specific terms but no equivalent pharmacy-specific term. RESULTS: The search of the MeSH thesaurus identified 145 terms representing dentistry-specific activities and 94 and 26 terms specific to nursing and pharmacy practice, respectively. Analysis of the three sets of MeSH terms indicated that dentistry-oriented MeSH terms were generally situated more prominently within the MeSH hierarchy than terms for nursing- and pharmacy-oriented research; the MeSH terminology oriented toward nursing or dentistry practice was relatively more granular, allowing for increased specificity and power of information retrieval during PubMed and MEDLINE searches. Seventeen proposed new MeSH terms describing key areas of pharmacy practice were identified; the inclusion of these terms in the MeSH hierarchy could substantially expand and improve the retrievability of NLM-indexed literature. CONCLUSION: Imbalances and gaps were found in MeSH coverage of pharmacy concepts and terminology relative to MeSH terminology specific to the nursing and dentistry professions.

Renal nurses' views of the potential role of pharmacists in outpatient dialysis centres: a qualitative study.

OBJECTIVES: The aim of this study was to explore the differences in the views of Australian and Portuguese renal nurses on the provision of clinical pharmacy services in outpatient dialysis centres. METHODS: Semi-structured interviews were conducted with Australian and Portuguese renal nurses. The interviews were recorded and thematically content-analysed. KEY FINDINGS: Three main themes were identified: nurses' opinions towards pharmacists' current role; nurses' opinions towards pharmacists' future role; and future clinical pharmacy services to be provided. While Australian nurses appeared to be aware of pharmacists' competencies and viewed a role for pharmacists within the team, Portuguese nurses showed low expectations of pharmacists and regarded them as external to the team. CONCLUSIONS: Previous or lack of exposure to pharmacists' clinical skills and the existence of health policies that promote interprofessional collaboration appear to influence nurses' views.