Monitoring real-life utilization of pembrolizumab in advanced melanoma using the Portuguese National Cancer Registry.

OBJECTIVES: To evaluate the effectiveness and safety of pembrolizumab use in advanced melanoma in a real-life context; and to explore the existence of an efficacy-effectiveness gap, comparing registry data with the reference clinical trial. METHODS: This study followed the guidelines for good pharmacoepidemology practice. An ambispective cohort was constituted, initiating the observation upon drug approval (17/07/2015) and following exposed patients until death or cut-off date (15/11/2019). The primary outcome was overall survival (OS); secondary outcomes comprised progression-free survival (PFS), overall response rate (ORR) and the occurrence of adverse events (AE). For all survival analyses, the Kaplan-Meier estimator was used, considering a 95% confidence interval (CI), aside with one-year survival rates. RESULTS: A total of 125 patients constituted the cohort, originating from 16 hospitals in Portugal. Median OS was estimated to be 16.9 months (CI95% 11.3-25.5) and the probability of survival after 1 year was 57.5% (CI95% 48.4%-65.6%). Median PFS was estimated to be 4.8 months (CI95% 3.9-6.7) and the probability of remaining progression-free after 1 year was 32.8% (CI95% 24.8-41.1). ORR was 30.4% (CI95% 22.5%-39.3%). AEs were experienced by 82% of patients, and 27% experienced AE≥ grade 3. CONCLUSIONS: Our data suggest lower effectiveness in a real-life context than the efficacy reported in the clinical trial. Safety data seems, however, quite comparable to KEYNOTE-006.

Primary health care policy and vision for community pharmacy and pharmacists in Portugal.

The central role of the Portuguese National Health Service (P-NHS) guarantees virtually free universal coverage. Key policy papers, such as the National Health Plan and the National Plan for Patient Safety have implications for pharmacists, including an engagement in medicines reconciliation. These primary health care reform, while not explicitly contemplating a role for pharmacists, offer opportunities for the involvement of primary care pharmacists in medicines management. Primary care pharmacists, who as employees of the P-NHS work closely with an interdisciplinary team, have launched a pilot service to manage polypharmacy in people living with multimorbidities, involving potential referral to community pharmacy. Full integration of community pharmacy into primary health care is challenging due to their nature as private providers, which implies the need for the recognition that public and private health sectors are mutually complementary and may maximize universal health coverage. The scope of practice of community pharmacies has been shifting to service provision, currently supported by law and in some cases, including the needle and syringe exchange program and generic substitution, remunerated. Key changes envisaged for the future of pharmacists and their integration in primary care comprise the development and establishment of clinical pharmacy as a specialization area, peer clinician recognition and better integration in primary care teams, including full access to clinical records. These key changes would enable pharmacists to apply their competence in medicines optimization for improved patient outcomes.

A survey to assess the availability, implementation rate and remuneration of pharmacist-led cognitive services throughout Europe.

BACKGROUND: Pharmacist-led cognitive services (PLCS) are increasingly necessary in primary care as a response to patient-centered care. However, the implementation rate and remuneration models of PLCS are either absent or superficially described in the literature. OBJECTIVE: The aim of this study is to review the implementation of PLCS in primary care across Europe and explore the associated third-party paid remuneration models. METHODS: A cross-sectional study was conducted using an online survey sent to representatives of 44 European countries. The survey listed 21 PLCS and asked respondents to report the availability of the service, the rate of implementation and the existence of remuneration. To ensure credible data, data triangulation was sought using three representatives per country, representing backgrounds of community pharmacy, pharmacy practice research and health policy. Subsequently, data was validated, and consensus sought. RESULTS: Data were collected between November 2016 and October 2017 from 34 different countries across Europe (79%). Provision of medicines' information (94.1%), generic substitution (85.3%), provision of emergency oral contraception (70.6%) and point-of-care testing (67.7%) were the services reported as the most widely disseminated in European primary care. Medication review was the most disseminated among advanced services (55.9%). Medication review, adherence support and monitoring, prescription renewal, opioid substitution and travel medicine had the highest implementation rates reported. Half of the participating countries mentioned models of remuneration, predominantly based on a fee-for-service, with less frequent reports of pay-for-performance or mixed models of remuneration. CONCLUSIONS: The availability of PLCS is increasing and varying in scope across Europe. There is wide variation in the implementation level of services across Europe and a lack of valid data. Remuneration of PLCS is also spreading but no clear pattern was found that relates service provision to payment.

Community pharmacist-led medication review procedures across Europe: Characterization, implementation and remuneration.

BACKGROUND: Pharmaceutical Care Network Europe (PCNE) proposed a definition and classification system (type 1, 2a, 2b, 3) for medication review in 2016. However, to date, a description of the implementation and remuneration of such procedures across Europe is lacking. OBJECTIVE: The aim of this study was to describe the medication review procedures and the level of implementation and remuneration in community pharmacies across Europe. METHODS: An online survey was developed to characterize medication review procedures (PCNE classification), level of implementation (considering regional or national) and remuneration by a third party. This survey was sent to a purposive sample of three individuals per country, with a working background in community pharmacy, pharmacy practice research, or health policy to ensure reliable data. Data triangulation was used and consensus sought between the responses. RESULTS: Data were received from 34 out of 44 targeted European countries (November 2016-October 2017) [response rate = 77%]. Overall, 55.9% of the countries provided at least one type of medication review as an implemented service or project. Type 1 medication review (based on the medication history) was provided in 13 countries, type 2a (medication history + patient interview) in 14, type 2b (medication history + clinical data) in two, and type 3 medication review (medication history + patient interview + clinical data) in four countries. Ten of the mentioned services or projects were remunerated by a third-party. CONCLUSION: Substantial heterogeneity was observed across Europe in various aspects, including the procedures, implementation level and remuneration obtained. Type 1 and 2a medication review services seem to be more feasible to implement in the community pharmacy than type 2b and 3. A large number of medication review projects were ongoing in community pharmacies, which suggests that new medication review services could become implemented in the coming years.

Contribution of Different Patient Information Sources to Create the Best Possible Medication History.

INTRODUCTION: Obtaining the best possible medication history is the crucial step in medication reconciliation. Our aim was to evaluate the potential contributions of the main data sources available - patient/caregiver, hospital medical records, and shared electronic health records - to obtain an accurate 'best possible medication history'. MATERIAL AND METHODS: An observational cross-sectional study was conducted. Adult patients taking at least one medicine were included. Patient interview was performed upon admission and this information was reconciled with hospital medical records and shared electronic health records, assessed retrospectively. Concordance between sources was assessed. In the shared electronic health records, information was collected for four time-periods: the preceding three, six, nine and 12-months. The proportion of omitted data between time-periods was analysed. RESULTS: A total of 148 patients were admitted, with a mean age of 54.6 ± 16.3 years. A total of 1639 medicines were retrieved. Only 29% were collected simultaneously in the three sources of information, 40% were only obtained in shared electronic health records and only 5% were obtained exclusively from patients. The total number of medicines gathered in shared electronic health records considering the different time frames were 778 (three-months), 1397 (six-months), 1748 (nine-months), and 1933 (12-months). DISCUSSION: The use of shared electronic health records provides data that were omitted in the other data sources available and retrieving the information at six months is the most efficient procedure to establish the basis of the best possible medication history. CONCLUSION: Shared electronic health records should be the preferred source of information to supplement the patient or caregiver interview in order to increase the accuracy of best possible medication history of the patient, particularly if collected within the prior six months.

Introdução: A obtenção da melhor história farmacoterapêutica possível é uma etapa crucial da reconciliação da medicação. O objetivo foi avaliar as potenciais contribuições das principais fontes de informação disponíveis ­ doente/cuidador, Processo Único, Plataforma de Dados da Saúde e ­ para obter uma mais exacta melhor história farmacoterapêutica possível. Material e Métodos: Foi realizado um estudo transversal observacional. Incluíram-se doentes adultos a tomar pelo menos um medicamento. A entrevista com o doente foi realizada na admissão e os dados do Processo Único e da Plataforma de Dados da Saúde recolhidos retrospetivamente. A concordância entre as fontes de informação foi avaliada. Na plataforma de dados da saúde, os dados foram recolhidos em quatro janelas temporais: os últimos três, seis, nove e 12- meses. Os dados omitidos entre os diferentes tempos foram analisados. Resultados: Participaram 148 doentes, com uma idade média de 54,6 ± 16,3 anos. Foram recolhidos 1639 medicamentos. Destes, 29% foram obtidos simultaneamente nas três fontes de informação, 40% foram obtidos apenas na Plataforma de Dados da Saúde e 5% foram obtidos exclusivamente a partir do doente. O número total de fármacos recolhidos na Plataforma de Dados da Saúde nos diferentes tempos foi 778 (três meses), 1397 (seis meses), 1748 (nove meses) e 1933 (12 meses). Discussão: A consulta da Plataforma de Dados da Saúde permite obter dados omitidos nas outras fontes de informação e a recolha dos seis meses precedentes é o procedimento mais eficiente para constituir a base da melhor história farmacoterapêutica possível. Conclusão: A Plataforma de Dados da Saúde deve ser a fonte de informação preferencial para complementar a entrevista do doente/cuidador de forma a aumentar a exatidão da melhor história farmacoterapêutica possível, particularmente se a informação for recolhida em relação aos seis meses precedentes.

The South Region Cancer Registry: an evaluation of its exhaustiveness in a cohort of lung cancer patients.

The regional cancer registry for Southern Portugal (ROR-Sul) is a population-based registry set up in 1988 to observe and monitor disease incidence, prevalence and survival. Recently, the need to monitor real-life use of early approved and high-priced medicines led to therapeutic effectiveness becoming an emerging area of interest. We aimed to evaluate the exhaustiveness of the ROR-Sul database, covering around 4.8 million inhabitants. We have used a retrospective cohort study comprising 3457 lung cancer cases diagnosed during 2014 and 2015 and extracted from ROR-Sul database. Descriptive analysis of missing data was undertaken using IBM SPSS software, v.24. Exhaustiveness of data registry was classified into high (missing values <1%), medium (missing values {1-15%}) or low (missing values > 15%). High exhaustiveness was found for patients demographic information, date of diagnosis, date of first medical appointment, topography, morphology, cancer differentiation, stage of disease and surgery procedure. Medium exhaustiveness was found for biomarkers (ALK, KRAS, and EGFR) results, and immunotherapy regimens. Low exhaustiveness was found for performance status, chemotherapy regimen, and chemotherapy treatment response. The findings highlight the need to transform treatment variables into compulsory, so that the cancer registry may be used to support effectiveness studies. Education, training and behaviour changes must also be considered to foster the process.

The social value of pharmaceutical interventions, the Portuguese contribution to sustainable development.

This commentary focuses on a description of solidarity initiatives developed by pharmacists in different practice areas. These are varied initiatives which contribute to improve the life of human beings in a wide range of formats with one common vector, the pharmacist's involvement. Each of the initiatives described is related to the sustainable development goal it contributes to, whilst also referring to its link to international health policy documents, mostly issued by FIP. We expect this commentary further contributes to boost such initiatives in other parts of the world.

Provision of pharmaceutical care by community pharmacists across Europe: Is it developing and spreading?

RATIONALE, AIMS, AND OBJECTIVES: Pharmaceutical care involves patient-centred pharmacist activity to improve medicines management by patients. The implementation of this service in a comprehensive manner, however, requires considerable organisation and effort, and indeed, it is often not fully implemented in care settings. The main objective was to assess how pharmaceutical care provision within community pharmacy has evolved over time in Europe. METHOD: A cross-sectional questionnaire-based survey of community pharmacies, using a modified version of the Behavioural Pharmaceutical Care Scale (BPCS) was conducted in late 2012/early 2013 within 16 European countries and compared with an earlier assessment conducted in 2006. RESULTS: The provision of comprehensive pharmaceutical care has slightly improved in all European countries that participated in both editions of this survey (n = 8) with progress being made particularly in Denmark and Switzerland. Moreover, there was a wider country uptake, indicating spread of the concept. However, due to a number of limitations, the results should be interpreted with caution. Using combined data from participating countries, the provision of pharmaceutical care was positively correlated with the participation of the community pharmacists in patient-centred activities, routine use of pharmacy software with access to clinical data, participation in multidisciplinary team meetings, and having specialized education. CONCLUSIONS: The present study demonstrated a slight evolution in self-reported provision of pharmaceutical care by community pharmacists across Europe, as measured by the BPCS. The slow progress suggests a range of barriers, which are preventing pharmacists moving beyond traditional roles. Support from professional bodies and more patient-centred community pharmacy contracts, including remuneration for pharmaceutical care services, are likely to be required if quicker progress is to be made in the future.

Determinants of self-medication with NSAIDs in a Portuguese community pharmacy.

BACKGROUND: Non-steroid anti-inflammatory drugs (NSAIDs) are a widely used therapeutic group in the world, and particularly in the Portuguese population. OBJECTIVE: To compare NSAID's use by prescription and self-medication acquisition and to determine the pattern of indication of NSAIDs, their usage profile and possible implications for patients' safety. METHODS: A cross-sectional design was used where individuals presenting at a community pharmacy requesting NSAIDs during the study period (one month) were invited to answer a face-to-face interview where socio-demographic characteristics, the indication pattern and previous experience of side effects were assessed. A follow-up interview was performed one week later to assess the incidence of adverse effects. The study was ethically approved. RESULTS: A sample of 130 NSAIDs users was recruited, comprising mostly women (n=87; 66.9%), actively employed (n=77; 59.2%) and presenting a mean age of 49.5 years old (SD=20.49). An equal proportion of individuals acquired NSAIDs by self-medication and with medical prescription (n=65; 50%). Over 4/5 of patients (n=57; 87.7%) acquiring NSAIDs without a prescription were self-medicated by their own initiative, and only 10.8% (n=7) had been advised by the pharmacist. The most commonly acquired active substances were ibuprofen and diclofenac. Self-medicated users more frequently resorted to topical NSAIDs following short term treatments. The major underlying condition motivating NSAIDs sought were musculoskeletal disorders (45.0%), regardless of the regimen. An important proportion of prevalent users of NSAIDs reported previous experience of adverse effects (11.3%). One week after initiating NSAID therapy, a small proportion of patients reported incidence of adverse effects. CONCLUSION: Self-medication with NSAIDs is sought for numerous medical conditions. Reported adverse effects (prevalent and incident) confirm the need for a more rational use of NSAIDs and ongoing pharmacovigilance.

Impact of pharmaceutical counseling in minor health problems in rural Portugal.

OBJECTIVES: The objectives of this study were to determine the prevalence of self-medication and to evaluate the clinical impact of pharmaceutical counseling. METHODS: A cross-sectional study was used with a prospective component, the latter to evaluate the impact of pharmaceutical counseling. The study was conducted in a rural community pharmacy for 14 consecutive days in December 2012, recruiting all individuals who agreed to participate and met the eligibility criteria. During a face-to-face direct interview demographic and clinical characteristics of patients were registered, followed by a pharmaceutical intervention, which consisted of evaluating the symptoms, selecting the most appropriate non-prescription medicine (NPM) available and advising the patient on pharmacologic and non-pharmacologic measures, all according to established protocols for minor health problems. When appropriate, the patient was referred to a medical appointment. One week later, the clinical outcome of such intervention was measured by asking the patients about the resolution of their minor health problems. RESULTS: Data from 298 patients were analyzed, the majority being female (60.1%) with an average age of 44.84 years (SD=22.41). Respiratory problems were the most frequent (n=78; 26.2%) and respiratory tract medication was the most frequently indicated (n= 77; 27.8%). The observed prevalence of self-medication was 40.7%. Of the 271 patients' beneficiaries of pharmaceutical counseling, 86.8% had their minor health problems solved after one week (ranging from 77.5% to 88.2% according to a sensibility analysis for drop-outs). CONCLUSIONS: This work is important as it demonstrates the beneficial impact of pharmaceutical counseling, a very relevant area for the pharmacist and where literature is particularly scarce.

Validation of a survey tool for use in cross-cultural studies.

UNLABELLED: There is a need for tools to measure the information patients need in order for healthcare professionals in general, and particularly pharmacists, to communicate effectively and play an active part in the way patients manage their medicines. Previous research has developed and validated constructs to measure patients' desires for information and their perceptions of how useful their medicines are. It is important to develop these tools for use in different settings and countries so that best practice is shared and is based on the best available evidence. OBJECTIVES: this project sought to validate of a survey tool measuring the "Extent of Information Desired" (EID), the "Perceived Utility of Medicines" (PUM), and the "Anxiety about Illness" (AI) that had been previously translated for use with Portuguese patients. METHODS: The scales were validated in a patient sample of 596: construct validity was explored in Factor analysis (PCA) and internal consistency analysed using Cronbach's alpha. Criterion validity was explored correlating scores to the AI scale and patients' perceived health status. Discriminatory power was assessed using ANOVA. Temporal stability was explored in a sub-sample of patients who responded at two time points, using a T-test to compare their mean scores. RESULTS: Construct validity results indicated the need to remove 1 item from the Perceived Harm of Medicines (PHM) and Perceived Benefit of Medicines (PBM) for use in a Portuguese sample and the abandon of the tolerance scale. The internal consistency was high for the EID, PBM and AI scales (alpha>0.600) and acceptable for the PHM scale (alpha=0.536). All scales, except the EID, were consistent over time (p>0.05; p<0.01). All the scales tested showed good discriminatory power. The comparison of the AI scale with the SF-36 indicated good criterion validity (p<0.05). CONCLUSION: The translated tool was valid and reliable in Portuguese patients-excluding the Tolerance scale. Some of the scales may benefit from further refinement, such as the PHM subscale.

A systematic approach to cross-cultural adaptation of survey tools.

BACKGROUND: Involving patients in health care is increasingly acknowledged as the best way to empower patients to manage their illness. Whilst the involvement of patients is laudable and widely recognised, how much they want to be involved needs to be ascertained. Research has shown that inappropriate provision of information to patients can increase their anxieties towards illness and alter perceptions of medicines' usefulness, consequently impacting on medicines' taking behaviour. Tools have been validated in the UK to identify information desires, perceived usefulness of medicines and anxiety felt about illness. There is a need to adapt validated tools for use in other settings and countries. This paper is the first of a series describing the processes involved in the adaptation and validation of these. AIM: to review and adapt the processes established to translate and back translate scales and tools in practice. METHODS: The survey tool was translated and back- translated according to published guidelines, subsequently tested in a sample of medical patients and further refined by seeking health care professionals' perceptions and input from lay people. RESULTS: Data demonstrates the importance of including various perspectives in this process, through which sequential modifications were made to the original scales. Issues relating to religious beliefs, educational and health literacy differences between countries highlight the relevance of taking cultural values into account. Some led to significant modifications, discussed in this first paper, and tested for validity and reliability in a second paper.

Monitoring quality standards in the provision of non-prescription medicines from Australian Community Pharmacies: results of a national programme.

INTRODUCTION: Standards of practice have been developed by the pharmacy profession to address the provision of non-prescription medicines, using a consumer-focused and risk management approach. The application of these standards in Australian community pharmacies has been monitored since 2002 by the Quality Care Pharmacy Support Centre (QCPSC). METHODS: Between September 2002 and September 2005, 7785 standards maintenance assessment visits were conducted in 4282 pharmacies, using pseudo-patient methodology. 1909 were symptom-based requests (SBRs) and 5876 were direct product-based requests (DPRs), of which 2864 were for pharmacist-only medicines (POMs) and 3012 were for pharmacy medicines (PMs). 2756 pharmacies received two visits, and 747 received three visits. A pharmacy's performance was scored out of 10 at each visit (scores 0-3: "unsatisfactory"; 4-6: "satisfactory"; and 7-10: "excellent"). RESULTS: There was wide variation in performance at baseline, with 1453 (34%) of pharmacies scoring