Pharmaceutical pictograms to improve textual comprehension: A systematic review.

INTRODUCTION: Written instructive information for the patient is key in pharmaceutical care. However, the preexisting literature agrees on the discordance between the readability of written medication messages intended for patients. The aim of our work was to systematically review the available evidence on the effect of pharmaceutical pictograms as elements that facilitate understanding of the text in primary or secondary medication packaging. METHODS: A parallel systematic search was conducted of the literature covering evidence of the effect of including pictograms in primary or secondary packaging on comprehension by potential users or caregivers up to April 9, 2023. The databases consulted were Scopus, MEDLINE and Web of Science. Only randomized controlled studies, whose main outcome measure was comprehension, were included. RESULTS: Only 8 papers met our search criteria. In most of the included studies, the intervention of including pictograms improved participants' performance in comprehending instructions. A debatable methodological quality, and differences in the target population, textual complexity of the materials or the cultural affinity of the pictograms with the target population in each study, could have had a decisive influence on the results. CONCLUSION: The heterogeneity in the design of each study poses a significant barrier to establishing commonalities and generalizing the results. This heterogeneity also prevented us from conclusively confirming the usefulness of pictograms complementary to instructional text in improving the comprehension of instructions for the rational use of medicines.

Patient participation in research projects in Community Pharmacies: An exploratory study

Introducción: En los últimos años ha habido un incremento de la participación de farmacias comunitarias en proyectos de investigación. El reclutamiento de pacientes juega un papel clave en el éxito de las investigaciones. Se han identificado barreras y facilitadores que promueven dicho reclutamiento por parte de los farmacéuticos, pero poco es sabido sobre la influencia de factores relacionados con los proyectos de investigación. El objetivo de este trabajo es observar la participación en diferentes investigaciones llevadas a cabo en farmacias comunitarias e identificar las variables propias de los estudios que puedan estar asociadas con la participación.Método: Se realizó un estudio multicéntrico experimental en 12 farmacias comunitarias que formaron parte de 4 proyectos de investigación. Se registró el número de pacientes que aceptaron/rechazaron participar. Se recogieron variables relacionadas con el estudio ofrecido y las farmacias. Se realizó un análisis bivariante mediante la prueba Chi-Cuadrado de Pearson y un análisis de los riesgos.Resultados: La participación total fue del 90,44 % (n=558). El tipo de estudio (OR=2,64; 95 %IC=1,47-4,75; trans-versal vs pragmático), el tipo de medida aplicada (OR=2,47; 95 %IC=1,43-4,36), la aplicación de zona de atención personalizada (ZAP) (OR=2,49; 95 %IC=1,44-4,39), y la solicitud de datos personales (OR=2,53; 95 %CI=1,47-4,42) mostraron asociación con la participación en los PI (p<0,05).Conclusiones: La participación por parte de los pacientes en proyectos de investigación es elevado y parece de-pender de factores propios del estudio aplicado. (AU)

Introduction: Over the last years there has been an increase in community pharmacy participation in research projects. Patient recruitment plays a key role in the research project success. Pharmacists’ barriers and enablers of recruitment have been identified, but little is known about the influence of research project-related factors. The aim of this paper is to explore patient participation in different studies conducted in community pharmacies and to identify study-specific factors that may be associated with it.Method: An experimental multicenter study was performed in 12 community pharmacies participating in 4 research projects. The number of patients who accepted/refused to participate was recorded. Variables related to each of-fered study and the project were collected. A bivariate analysis using Pearson’s Chi-Square test and a risk analysis were performed.Results: Participation rate was 90.44 % (n=558). Study type (OR=2.64; 95 % CI=1.47-4.75; cross-sectional vs prag-matic), the type of measurement applied (OR=2.47; 95 % CI=1.43-4.36), the use of a personalized care area (PCA) (OR=2.49; 95 % CI=1.44-4.39), and personal data request (OR=2.53; 95 %CI=1.47-4.42) showed association with par-ticipation in the RP (p<0.05).Conclusions: Patient participation in research projects is high and appears to rely on study-specific factors. (AU)

Impacto de la adición de pictogramas farmacéuticos como ayuda visual sobre la comprensión de prospectos en estudiantes de educación secundaria / Impact of the addition of pharmaceutical pictograms as visual aids on the comprehension of package inserts in students completing secondary education

Introducción: La Atención Farmacéutica requiere que los pacientes comprendan la información brindada. La inclusión de ayudas visuales podría mejorar la comprensión de textos complejos como son los prospectos de los medicamentos. Nuestro objetivo fue evaluar los efectos de la inclusión de pictogramas farmacéuticos sobre la comprensión de instrucciones elementales para el uso de medicamentos por estudiantes que finalizan la enseñanza básica. Método: De un total de 309 alumnos participantes, se aleatorizaron 160 para leer tres prospectos de medicamentos de uso frecuente (ibuprofeno, amoxicilina/ácido clavulánico y omeprazol), mientras que 149 recibieron pictogramas junto a los prospectos. La aleatorización fue alterna según la posición de los alumnos en el aula. La comprensión fue estimada mediante cuestiones básicas del uso de medicamentos. Resultados: En el grupo control solo el 38.75% de los alumnos contestaron correctamente cuándo tomar el ibuprofeno en relación a las comidas el 32.25% acertaron cual es la dosis habitual del antibiótico y el 61.88% identificó la indicación del omeprazol. En los tres casos, se encontraron diferencias significativas en favor de la comprensión en el grupo experimental (OR = 1.93; 95% IC, 1.23 – 3.05; p = 0.0041, OR = 3.87; 95% IC, 2.43 – 6.25; p = 10-7 y OR = 3.55; 95% IC, 2.07 – 6.29; p = 3.67x10-5 respectivamente). Conclusiones: La inclusión de pictogramas farmacéuticos en los prospectos es una estrategia sencilla que podría potencialmente favorecer el uso racional del medicamento. (AU)

Introduction: Pharmaceutical Care requires that patients understand the information provided. The inclusion of visual aids could improve the comprehension of complex texts such as drug package inserts. Our objective was to evaluate the effects of the inclusion of pharmaceutical pictograms on the comprehension of elementary instructions for the use of drugs by students completing basic education. Methods: Among a total of 309 participating students, 160 were randomized to read three frequently used drug package inserts (ibuprofen, amoxicillin/clavulanic acid and omeprazole), while 149 received pictographs together with the package inserts. Randomization was alternated according to the position of the students in the classroom. Comprehension was estimated by means of basic questions on the use of drugs. Results: In the control group only 38.75% of the students answered correctly when to take ibuprofen in relation to meals, 32.25% were right about the usual dose of the antibiotic and 61.88% identified the indication for omeprazole. In all three cases, significant differences in favor of understanding were found in the experimental group (OR = 1.93; 95% CI, 1.23 - 3.05; p = 0.0041, OR = 3.87; 95% CI, 2.43 - 6.25; p = 10-7 and OR = 3.55; 95% CI, 2.07 - 6.29; p = 3.67x10-5 respectively). Conclusions: The inclusion of pharmaceutical pictograms in package inserts is a simple strategy that could favor potentially the rational use of drugs. (AU)

Association of Single-Nucleotide Polymorphisms in Capecitabine Bioactivation Pathway with Adjuvant Therapy Safety in Colorectal Cancer Patients.

Capecitabine, an oral prodrug of 5-fluorouracil (5-FU), is part of the standard treatment of colorectal cancer (CRC). Severe adverse dose limiting reactions that impair treatment safety and lead to treatment suspension remain a relevant concern. Single-nucleotide polymorphisms (SNPs) in genes involved in the activation of capecitabine may alter the bioavailability of 5-FU and thereby affect therapy outcomes. The aim of this study was to evaluate the association of these SNPs with severe toxicity and treatment suspension in patients with CRC treated with capecitabine-based therapy. An ambispective cohort study was conducted, including 161 patients with CRC. SNPs were analyzed using real-time PCR with TaqMan® probes. Toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events v.5.0. CES1 rs71647871-A was associated with a severe hand-foot syndrome (p = 0.030; OR = 11.92; 95% CI = 1.46-73.47; GG vs. A). CDA rs1048977-CC (p = 0.030; OR = 2.30; 95% CI 1.09-5.00; T vs. CC) and capecitabine monotherapy (p = 0.003; OR = 3.13; 95% CI 1.49-6.81) were associated with treatment suspension due to toxicity. SNPs CES1 rs71647871 and CDA rs1048977 may act as potential predictive biomarkers of safety in patients with CRC under capecitabine-based adjuvant therapy.

ABCC1, ABCG2 and FOXP3: Predictive Biomarkers of Toxicity from Methotrexate Treatment in Patients Diagnosed with Moderate-to-Severe Psoriasis.

BACKGROUND: Methotrexate (MTX) is one of the most extensively used drugs in the treatment of moderate-to-severe psoriasis (PS). However, it frequently must be suspended owing to the toxicity in certain patients. OBJECTIVE: To evaluate the influence of ABCC1, ABCG2, and FOXP3 in the development of MTX toxicity in PS. METHODS: Retrospective cohort study with 101 patients. Five single-nucleotide polymorphisms (SNPs) were genotyped using real-time polymerase chain reaction with TaqMan probes. RESULTS: Patients carrying ABCC1 rs2238476-AG genotype (AG vs. GG: OR = 8.04; 95% CI = 1.48-46.78; p = 0.015); FOXP3 rs376154-GT and GG genotypes (GT vs. TT/GG: OR = 3.86; 95% CI = 1.17-13.92; p = 0.031) and ABCG2 rs13120400-T allele (T vs. CC: OR = 8.33; 95% CI = 1.24-164.79; p = 0.059) showed a higher risk of developing more than one adverse effect. The toxicity analysis by subtypes showed that the ABCC1 rs2238476-AG genotype (AG vs. GG: OR = 8.10; 95% CI = 1.69-46.63; p = 0.011) and FOXP3 rs376154-GT genotype (OR = 4.11; 95% CI = 1.22-15.30; p = 0.027) were associated with the appearance of asthenia. No association of the other ABCC1 polymorphisms (rs35592 and rs246240) with MTX toxicity was found. CONCLUSION: ABCC1, ABCG2, and FOXP3 polymorphisms can be considered to be risk biomarkers of toxicities in PS patients treated with MTX.

Single Nucleotide Polymorphisms in the Vitamin D Metabolic Pathway as Survival Biomarkers in Colorectal Cancer.

Several studies have suggested that single nucleotide polymorphisms (SNPs) related to vitamin D metabolism may affect CRC carcinogenesis and survival. The aim of this study was to evaluate the influence of 13 SNPs involved in the vitamin D metabolic pathway on CRC survival. We conducted an observational retrospective cohort study, which included 127 Caucasian CRC patient from the south of Spain. SNPs in VDR, CYP27B1, CYP2R1, CYP24A1, and GC genes were analyzed by real-time polymerase chain reaction. Progression-free survival (PFS) and overall survival (OS) were assessed. Cox regression analysis adjusted for metastasis, age of diagnosis, stage (IIIB, IV or IVB), ECOG score (2-4), lymph node involvement, adjuvant chemotherapy, and no family history of CRC showed that the VDR ApaI (p = 0.036), CYP24A1 rs6068816 (p < 0.001), and GC rs7041 (p = 0.006) were associated with OS in patients diagnosed with CRC, and CYP24A1 rs6068816 (p < 0.001) was associated with PFS adjusted for metastasis, age of diagnosis, stage (IIIB, IV or IVB), ECOG score (2-4), lymph node involvement, adjuvant chemotherapy, and no primary tumor resection. The rest of the SNPs showed no association with CRC survival. Thus, the SNPs mentioned above may have a key role as prognostic biomarkers of CRC.

Influence of Single-Nucleotide Polymorphisms on Clinical Outcomes of Capecitabine-Based Chemotherapy in Colorectal Cancer Patients: A Systematic Review.

The aim of this systematic review was to provide a comprehensive overview of the literature published in the last decade on the association of single-nucleotide polymorphisms in genes involved in the pharmacodynamic and pharmacokinetic pathways of capecitabine with treatment outcomes among colorectal cancer patients. A systematic search of the literature published in the last 10 years was carried out in two databases (Medline and Scopus) using keywords related to the objective. Quality assessment of the studies included was performed using an assessment tool derived from the Strengthening the Reporting of Genetic Association (STREGA) statement. Thirteen studies were included in this systematic review. Genes involved in bioactivation, metabolism, transport, mechanism of action of capecitabine, DNA repair, and folate cycle were associated with toxicity. Meanwhile, genes related to DNA repair were associated with therapy effectiveness. This systematic review reveals that several SNPs other than the four DPYD variants that are screened in clinical practice could have an impact on treatment outcomes. These findings suggest the identification of future predictive biomarkers of effectiveness and toxicity in colorectal cancer patients treated with capecitabine. However, the evidence is sparse and requires further validation.

Role of Single-Nucleotide Polymorphisms in Genes Implicated in Capecitabine Pharmacodynamics on the Effectiveness of Adjuvant Therapy in Colorectal Cancer.

Colorectal cancer (CRC) is a highly prevalent form of neoplasm worldwide. Capecitabine, an oral antimetabolite, is widely used for CRC treatment; however, there exists substantial variation in individual therapy response. This may be due to genetic variations in genes involved in capecitabine pharmacodynamics (PD). In this study, we investigated the role of single-nucleotide polymorphisms (SNPs) related to capecitabine's PD on disease-free survival (DFS) in CRC patients under adjuvant treatment. Thirteen SNPs in the TYMS, ENOSF1, MTHFR, ERCC1/2, and XRCC1/3 genes were genotyped in 142 CRC patients using real-time PCR with predesigned TaqMan® probes. A significant association was found between favorable DFS and the ENOSF1 rs2612091-T allele (p = 0.010; HR = 0.34; 95% CI = 0.14-0.83), as well as with the TYMS/ENOSF1 region ACT haplotype (p = 0.012; HR = 0.37; 95% CI = 0.17-0.80). Other factors such as low histological grade (p = 0.009; HR = 0.34; 95% CI = 0.14-0.79) and a family history of cancer (p = 0.040; HR = 0.48; 95% CI = 0.23-0.99) were also linked to improved DFS. Therefore, the SNP ENOSF1 rs2612091 could be considered as a predictive genetic biomarker for survival in CRC patients receiving capecitabine-based adjuvant regimens.

Clinical and economic aspects of chondroitin sulfate in osteoarthritis management: a brief review of recent evidence / Aspectos clínicos y económicos del sulfato de condroitina en el manejo de la artrosis: una revisión breve de la literatura reciente

Introduction: Chondroitin sulfate was proposed as a more appropriate strategy for osteoarthritis long-term management than conventional treatment (nonsteroidal anti-inflammatory drugs and acetaminophen). However, its efficacy has been widely discussed and its public financing by the Spanish National Health System has been questioned. The aim of this paper was review on the clinical and economic aspects of chondroitin sulfate in osteoarthritis treatment. Method: A bibliographic search of recent literature was carried out until March 9th, 2022. The databases used were MEDLINE and Scopus. Results: According to the set of clinical studies identified in the search, chondroitin sulfate was effective in reducing cartilage volume loss, its clinical effects were estimated by objective (magnetic resonance or specific biomarkers) and subjective (visual analog pain scale or Lequesne index) outcome measures. In the set of studies reviewed, chondroitin sulfate proved to be an acceptable therapeutic option in clinical terms. Regarding economic aspects, only one study was identified, according to which, the prescription of chondroitin sulfate implies a lower cost per patient compared to non-steroidal anti-inflammatory drugs. Conclusion: From the clinical and economic points of view, the findings of this brief review justify the presence of chondroitin sulfate in osteoarthritis guidelines. (AU)

Introducción: El sulfato de condroitina fue propuesto como una estrategia más apropiada para el manejo de la artrosis a largo plazo que los tratamientos convencionales (antiinflamatorios no esteroideos y paracetamol). Sin embargo, su eficacia ha sido ampliamente discutida y su financiación por el Sistema Español de Salud cuestionado. El objetivo de este trabajo fue realizar revisar los aspectos clínicos y económicos en el manejo del sulfato de condroitina en el tratamiento de la artrosis. Método: Se llevo a cabo una búsqueda de la literatura reciente hasta el 9 de marzo de 2022. Las bases de datos consultadas fueron MEDLINE y Scopus. Resultados: Según el conjunto de los estudios identificados, el sulfato de condroitina fue efectivo en la reducción de pérdida de volumen de cartílago causante del dolor y la rigidez articular. Sus efectos clínicos fueron estimados mediante medidas de resultado objetivas (resonancias magnéticas o biomarcadores específicos) y subjetivas (escala visual analógica de dolor o índice de Lequesne). El sulfato de condroitina mostró ser una opción terapéutica aceptable en términos clínicos. Respecto a los aspectos económicos, solo se identificó un estudio, según el cual, la prescripción de sulfato de condroitina implica un menor coste por paciente comparado con antiinflamatorios no esteroideos. Conclusión: Desde los puntos de vista clínico y económico, los hallazgos de esta breve revisión justifican la presencia del sulfato de condroitina en las guías medicas del manejo de la artrosis. (AU)

Estudio exploratorio de la participación en proyectos de investigación en Farmacias Comunitarias / Patient participation in research projects in Community Pharmacies: an exploratory study

Introducción: En los últimos años ha habido un incremento de la participación de farmacias comunitarias en proyectos de investigación. El reclutamiento de pacientes juega un papel clave en el éxito de las investigaciones. Se han identificado barreras y facilitadores que promueven dicho reclutamiento por parte de los farmacéuticos, pero poco es sabido sobre la influencia de factores relacionados con los proyectos de investigación. El objetivo de este trabajo es observar la participación en diferentes investigaciones llevadas a cabo en farmacias comunitarias e identificar las variables propias de los estudios que puedan estar asociadas con la participación.Método:Se realizó un estudio multicéntrico experimental en 12 farmacias comunitarias que formaron parte de 4 proyectos de investigación. Se registró el número de pacientes que aceptaron/rechazaron participar. Se recogieron variables relacionadas con el estudio ofrecido y las farmacias. Se realizó un análisis bivariante mediante la prueba Chi-Cuadrado de Pearson y un análisis de los riesgos. Resultados: La participación total fue del 90,44% (n=558). El tipo de estudio (OR=2,64; 95%IC=1,47-4,75; transversal vs pragmático), el tipo de medida aplicada (OR=2,47; 95%IC=1,43-4,36), la aplicación de zona de atención personalizada (ZAP) (OR=2,49; 95%IC=1,44-4,39), y la solicitud de datos personales (OR=2,53; 95%IC=1,47-4,42) mostraron asociación con la participación en los PI (p<0,05). Conclusiones: La participación por parte de los pacientes en proyectos de investigación es elevado y parece depender de factores propios del estudio aplicado (AU)

Introduction: Over the last years there has been an increase in community pharmacy participation in research projects. Patient recruitment plays a key role in the research project success. Pharmacists’ barriers and enablers of recruitment have been identified, but little is known about the influence of research project-related factors. The aim of this paper is to explore patient participation in different studies conducted in community pharmacies and to identify study-specific factors that may be associated with it. Method: An experimental multicenter study was performed in 12 community pharmacies participating in 4 research projects. The number of patients who accepted/refused to participate was recorded. Variables related to each offered study and the project were collected. A bivariate analysis using Pearson’s Chi-Square test and a risk analysis were performed. Results: Participation rate was 90.44% (n=558). Study type (OR=2.64; 95%IC=1.47-4.75; cross-sectional vs pragmatic), the type of measurement applied (OR=2.47; 95%CI=1.43-4.36), the use of a personalized care area (PCA) (OR=2.49; 95%CI=1.44-4.39), and personal data request (OR=2.53; 95%CI=1.47-4.42) showed association with participation in the RP (p<0.05). Conclusions: Patient participation in research projects is high and appears to rely on study-specific factors

Genetic polymorphisms on the effectiveness or safety of breast cancer treatment: Clinical relevance and future perspectives.

Breast cancer (BC) is the most frequent neoplasm and one of the main causes of death in women. The pharmacological treatment of BC consists of hormonal therapy, chemotherapeutic agents and targeted therapy. The response to BC therapy is highly variable in clinical practice. This variability can be explained by the presence of genetic polymorphisms in genes involved in the pharmacokinetics, pharmacodynamics or immune response of patients. The abundant evidence of associations between low-activity alleles CYP2D6*3, *4, *5, *6, *10 and *41 and poor results with tamoxifen therapy, and between DPYD gene polymorphisms rs3918290, rs55886062, rs67376798 and rs75017182 and increased risk of toxicity to fluoropyrimidine therapy, justify the existence of clinical pharmacogenetic guidelines. The NQO1 rs1800566 polymorphism is related to poorer results in BC therapy with chemotherapy agents. The polymorphism rs1695 of the GSTP1 gene has been associated with the effectiveness and toxicity of fluorouracil, cyclophosphamide and epirubicin therapy. Finally, the HLA-DQA1*02:01 allele is significantly associated with the occurrence of liver toxicity events in patients receiving lapatinib. There is moderate evidence to support the aforementioned associations and, therefore, a high probability of these being considered as future predictive genetic biomarkers of response. However, further studies are required to reinforce or clarify their clinical relevance.

Influence of Genetic Polymorphisms on Clinical Outcomes of Glatiramer Acetate in Multiple Sclerosis Patients.

Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of autoimmune origin, in which inflammation and demyelination lead to neurodegeneration and progressive disability. Treatment is aimed at slowing down the course of the disease and mitigating its symptoms. One of the first-line treatments used in patients with MS is glatiramer acetate (GA). However, in clinical practice, a response rate of between 30% and 55% is observed. This variability in the effectiveness of the medication may be influenced by genetic factors such as polymorphisms in the genes involved in the pathogenesis of MS. Therefore, this review assesses the impact of genetic variants on the response to GA therapy in patients diagnosed with MS. The results suggest that a relationship exists between the effectiveness of the treatment with GA and the presence of polymorphisms in the following genes: CD86, CLEC16A, CTSS, EOMES, MBP, FAS, TRBC1, IL1R1, IL12RB2, IL22RA2, PTPRT, PVT1, ALOX5AP, MAGI2, ZAK, RFPL3, UVRAG, SLC1A4, and HLA-DRB1*1501. Consequently, the identification of polymorphisms in these genes can be used in the future as a predictive marker of the response to GA treatment in patients diagnosed with MS. Nevertheless, there is a lack of evidence for this and more validation studies need to be conducted to apply this information to clinical practice.