Filipa Alves da Costa

Provision of pharmaceutical care by community pharmacists: a comparison across Europe

Objective To investigate the provision of pharmaceutical care by community pharmacists across Europe and to examine the various factors that could affect its implementation. Methods A questionnaire-based survey of community pharmacies was conducted within 13 European countries. The questionnaire consisted of two sections. The first section focussed on demographic data and services provided in the pharmacy. The second section was a slightly adapted version of the Behavioral Pharmaceutical Care Scale (BPCS) which consists of three main dimensions (direct patient care activities, referral and consultation activities and instrumental activities). Results Response rates ranged from 10–71% between countries. The mean total score achieved by community pharmacists, expressed as a percentage of the total score achievable, ranged from 31.6 (Denmark) to 52.2% (Ireland). Even though different aspects of pharmaceutical care were implemented to different extents across Europe, it was noted that the lowest scores were consistently achieved in the direct patient care dimension (particularly those related to documentation, patient assessment and implementation of therapeutic objectives and monitoring plans) followed by performance evaluation and evaluation of patient satisfaction. Pharmacists who dispensed higher daily numbers of prescriptions in Ireland, Germany and Switzerland had significantly higher total BPCS scores. In addition, pharmacists in England and Ireland who were supported in their place of work by other pharmacists scored significantly higher on referral and consultation and had a higher overall provision of pharmaceutical care. Conclusion The present findings suggest that the provision of pharmaceutical care in community pharmacy is still limited within Europe. Pharmacists were routinely engaged in general activities such as patient record screening but were infrequently involved in patient centred professional activities such as the implementation of therapeutic objectives and monitoring plans, or in self-evaluation of performance.

Effect of reminder cards on compliance with antihypertensive medication

Objective Poor compliance to antihypertensive medications has been identified as a primary cause of uncontrolled blood pressure (BP), with consequent increases in hypertension‐related morbidity and mortality. Therefore, any measure known to improve compliance should be encouraged. This study assessed the impact of reminder cards on compliance to antihypertensive therapy.

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.

Effects of economic recession on elderly patients’ perceptions of access to health care and medicines in Portugal

Background In view of the current financial and demographic situation in Portugal, accessibility to health care may be affected, including the ability to adhere to medication. Objective To evaluate the perceived effects of the crisis on elderly patient’s access to medicines and medical care, and its implications on medicine-taking behaviour. Setting Community pharmacy. Method A cross-sectional study was undertaken during April 2013, where elderly patients answered a self-administered questionnaire based on their health-related experiences in the current and previous year. Binary logistic regression was used to ascertain the effects of potential predictors on the likelihood of adherence. Main outcome measures self-reported adherence. Results A total of 1231 questionnaires were collected. 27.3% of patients had stopped using treatments or health services in the previous year for financial motives; mostly private medical appointments, followed by dentist appointments. Almost 30% of patients stopped purchasing prescribed medicines. Over 20% of patients reduced their use of public services. Out-of-pocket expenses with medicines were considered higher in the current year by 40.1% of patients. The most common strategy developed to cope with increasing costs of medicines was generic substitution, but around 15% of patients also stopped taking their medication or started saving by increasing the interdose interval. Conclusion Reports of decreasing costs with medicines was associated with a decreased likelihood of adherence (OR 0.42; 95% CI 0.27–0.65). Lower perceived health status and having 3 or more co-morbidities were associated with lower odds of adhering, whilst less frequent medical appointments was associated with a higher likelihood of exhibiting adherence.

Assessment of clinically relevant dose distributions in pelvic IOERT using Gafchromic EBT3 films

PURPOSE In IOERT a single dose of radiation is delivered to the tumour site during surgery. Manual dose calculations are used and the irradiation target volume, electron energy and applicator are decided on site by the radiation oncologist. This work assesses the effect that irregular and curved surfaces, typical of pelvic IOERT, may have on the expected dose distribution. METHODS The feasibility of using Gafchromic EBT3 films and a slab phantom to obtain 2D dose distributions was investigated. Different set-ups were tested by comparison with water tank measurements, applying the gamma function analysis with 2% and 2 mm criteria. The validated set-up was then used to obtain reference dose distributions, which were converted to colour-coded graphical representations. Phantoms with step-like and curved surfaces were created to simulate typical pelvic IOERT irradiation surfaces, and the dose distributions were obtained and compared with the reference distributions. RESULTS Good agreement with water tank measurements was obtained for all applicators below 2 mm, using the chosen setup in reference conditions. In non-reference conditions, the presence of a step-like surface creates an adjacent hotspot, followed by a quick reduction of the dose in depth. With curved surfaces, the dose distribution is shifted forward, becoming curved and deeper, but when the applicator is larger than the hole, hotspots are also observed. CONCLUSIONS The shape of the irradiation surfaces alters the dose distribution. Visualization of these effects is important to assess target coverage and interpret in vivo measurements in pelvic IOERT.

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

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.

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.

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.

Effects of shielding on pelvic and abdominal IORT dose distributions

PURPOSE To study the impact of shielding elements in the proximity of Intra-Operative Radiation Therapy (IORT) irradiation fields, and to generate graphical and quantitative information to assist radiation oncologists in the design of optimal shielding during pelvic and abdominal IORT. METHOD An IORT system was modeled with BEAMnrc and EGS++ Monte Carlo codes. The model was validated in reference conditions by gamma index analysis against an experimental data set of different beam energies, applicator diameters, and bevel angles. The reliability of the IORT model was further tested considering shielding layers inserted in the radiation beam. Further simulations were performed introducing a bone-like layer embedded in the water phantom. The dose distributions were calculated as 3D dose maps. RESULTS The analysis of the resulting 2D dose maps parallel to the clinical axis shows that the bevel angle of the applicator and its position relative to the shielding have a major influence on the dose distribution. When insufficient shielding is used, a hotspot nearby the shield appears near the surface. At greater depths, lateral scatter limits the dose reduction attainable with shielding, although the presence of bone-like structures in the phantom reduces the impact of this effect. CONCLUSIONS Dose distributions in shielded IORT procedures are affected by distinct contributions when considering the regions near the shielding and deeper in tissue: insufficient shielding may lead to residual dose and hotspots, and the scattering effects may enlarge the beam in depth. These effects must be carefully considered when planning an IORT treatment with shielding.

Using a cancer registry to capture signals of adverse events following immune and targeted therapy for melanoma

Background Toxicity of oncology treatments in real-life patients is frequently disregarded and hence underreported. Objective To characterize adverse events (AEs) of immunotherapy and targeted therapy reported in patients with locally advanced or metastatic melanoma. Setting District Hospital for Cancer treatment (Instituto Português de Oncologia de Lisboa Francisco Gentil). Method A retrospective cohort of melanoma patients was established, comprising adult patients diagnosed with malignant melanoma treated with immunotherapy or targeted therapy. Exposure was characterized by nature, time and intensity of exposure. To account for different exposure periods, person-time was used as unit of analysis. Main outcomes measure Occurrence of AEs. Results Data from 111 patients included in the cohort indicates the majority received immunotherapy regimens (CTLA-4, anti-PD-1 and combination therapy; (n = 70; 63.1%), among which anti-PD-1 were the predominant treatment. Pembrolizumab was the most frequently prescribed drug (n = 30; 45.7%). Three hundred and seventy-one AEs were extracted. The incidence of AEs was lower in the anti-PD-1 mAc group (54 AEs per 1000 person.months) and the number of AEs/patient was also lower (3.1 ± 2.0). Grade 3 to 4 AEs occurred in 15.3% (n = 17) of the cohort, being more common in the targeted therapy group. Forty-two (11.6%) of the extracted AEs were not described in the Summary of Product Characteristics of the drugs under study. Conclusion This study suggests various known and unknown AEs of immunotherapy and targeted therapy may be identified using the Cancer Registry database. These events should be considered as signals worth further investigation for assessment of causality as the underreporting of AEs in cancer may have potential implications for the patient’s quality of life.