Writing a manuscript for publication in a peer-reviewed scientific journal: Guidance from the European Society of Clinical Pharmacy.

Publishing in reputable peer-reviewed journals is an integral step of the clinical pharmacy research process, allowing for knowledge transfer and advancement in clinical pharmacy practice. Writing a manuscript for publication in a journal requires several careful considerations to ensure that research findings are communicated to the satisfaction of editors and reviewers, and effectively to the readers. This commentary provides a summary of the main points to consider, outlining how to: (1) select a suitable journal, (2) tailor the manuscript for the journal readership, (3) organise the content of the manuscript in line with the journal's guidelines, and (4) manage feedback from the peer review process. This commentary reviews the steps of the writing process, identifies common pitfalls, and proposes ways to overcome them. It aims to assist both novice and established researchers in the field of clinical pharmacy to enhance the quality of writing in a research paper to maximise impact.

Scope, content and quality of clinical pharmacy practice guidelines: a systematic review.

BACKGROUND: Guidelines for pharmacy practitioners regarding various clinical pharmacy activities have been published in a number of countries. There is a need to review the guidelines and identify the scope of activities covered as a prelude to developing internationally acceptable common guidelines. AIM: To review the scope of clinical pharmacy guidelines and assess the extent to which these guidelines conform to quality standards as per the AGREE II instrument. METHOD: Medline, Embase, Guideline Central, International Pharmaceutical Abstracts, Google Scholar and Google (for grey literature) were searched for the period 2010 to January 2023. Guidelines which focused on any health care setting and any clinical pharmacy activity were included. Data were extracted and quality assessed independently by two reviewers using the English version of the AGREE II instrument. RESULTS: Thirty-eight guidelines were included, mostly originating from Australia (n = 10), Ireland (n = 8), UK (n = 7) and USA (n = 5). Areas covered included medication reconciliation, medicines optimisation, medication management and transition of care. As per the AGREE II assessment, the highest score was obtained for the scope and purpose domain and the lowest score for rigour of development, mainly due to non-consideration of literature/evidence to inform guideline development. CONCLUSION: Clinical pharmacy guidelines development processes need to focus on all quality domains and should take a systematic approach to guideline development. Guidelines need to further emphasise person-centred care and clinical communication. There is a scope to harmonise the guidelines internationally considering the diverse practices, standards and legislations across different geographies.

How to write a successful grant application: guidance provided by the European Society of Clinical Pharmacy.

Considering a rejection rate of 80-90%, the preparation of a research grant is often considered a daunting task since it is resource intensive and there is no guarantee of success, even for seasoned researchers. This commentary provides a summary of the key points a researcher needs to consider when writing a research grant proposal, outlining: (1) how to conceptualise the research idea; (2) how to find the right funding call; (3) the importance of planning; (4) how to write; (5) what to write, and (6) key questions for reflection during preparation. It attempts to explain the difficulties associated with finding calls in clinical pharmacy and advanced pharmacy practice, and how to overcome them. The commentary aims to assist all pharmacy practice and health services research colleagues new to the grant application process, as well as experienced researchers striving to improve their grant review scores. The guidance in this paper is part of ESCP's commitment to stimulate "innovative and high-quality research in all areas of clinical pharmacy".

Perception of Interprofessional Education among Students Following Pharmacy Studies.

INTRODUCTION: Interprofessional Education (IPE) activities are a first experience of real-world patient care practice for students, where collaboration with different professions is appreciated. Methods and timing of inclusion of IPE are not well-defined, and it is interesting to assess students' perception on IPE activities. OBJECTIVE: To assess changes in pharmacy students' perception of IPE before (t0) and after (t1) an IPE activity. METHODS: The 'Student Perceptions of Interprofessional Clinical Education-Revised 2' (SPICE-R2) tool was adopted to assess perception of IPE activities in third year pharmacy students, final year pharmacy students and in postgraduate Doctorate in Pharmacy (PharmD) students at t0 and t1. RESULTS: The SPICE-R2 tool was completed at t0 and t1 by 61 students: 12 third year pharmacy students, 13 final year students and 36 PharmD students. A significant improvement between t0 and t1 (P < .05) was measured in the three groups of students for all three subscales of the tool. The largest improvement was observed in the 'Roles/Responsibilities for Collaborative Practice' subscale in all three groups of students. CONCLUSION: Perception of IPE was positively increased in all three student groups. The results could be useful to support the design of IPE activities within pharmacy programmes.

Pharmacist and physician perception of pharmacogenetic testing.

OBJECTIVES: To assess the perception of pharmacists and physicians towards pharmacogenetic testing. METHODS: A self-administered questionnaire was developed, validated, tested for reliability and disseminated to pharmacists and physicians in Malta. KEY FINDINGS: The study population consisted of 292 participants; 61% pharmacists (64% female, 38% practicing >10 years) and 39% physicians (50% female, 54% practicing >10 years). Pharmacists and physicians felt they lack sufficient competence in the area (95.0% and 97.4%, respectively; P > 0.05) and agreed that further training is required (92.7% and 91.2%, respectively; P > 0.05). CONCLUSIONS: The need for further training was identified by the participants to support competency development and sustain confidence on the topic, hence facilitating the clinical implementation of pharmacogenetic testing.

Developing and piloting a communication assessment tool assessing patient perspectives on communication with pharmacists (CAT-Pharm).

BACKGROUND: Effective communication strategies in health care help to enhance patient empowerment and improve clinical outcomes. OBJECTIVE: Adapt the original Communication Assessment (CAT) instrument for the pharmacist profession (CAT-Pharm) and to test its validity and reliability in two different settings. SETTING: Five hospital pharmacies in Italy and five community pharmacies in Malta. METHOD: Pilot study involving a standardized multi-step process adhering to internationally accepted and recommended guidelines. Corrections and adjustments to the translation addressed linguistic factors and cultural components. CAT-Pharm, compared to the original CAT, maintained 10 out of the 14 items: one was slightly modified; three were changed to better fit the pharmacist role; one was added. MAIN OUTCOME MEASURES: CAT-Pharm development and testing its practicality to assess patient perceptions of pharmacists' interpersonal and communication skills. RESULTS: CAT-Pharm was tested on 97 patients in the Italian setting and 150 patients in the Maltese setting to assess the practicality of the tool and its usefulness in investigating gaps and priorities for improving pharmacist-patient communication. Results Show reliability and internal validity of the CAT-Pharm tool. The analysis of patient perceptions of communication with the pharmacist in Italy indicated differences from that in Malta. The different settings provided insight into the utility of CAT-Pharm. CONCLUSION: This study provided a valid and reliable tool that could be applied to assess patient perception of the pharmacist's communication abilities.

CYP2C19*2 genetic polymorphism and incidence of in-stent restenosis in patients on clopidogrel: a matched case-control study.

OBJECTIVES: The cytochrome P450 2C19*2 (CYP2C19*2) genetic polymorphism is associated with reduced clopidogrel bioactivation, increasing the risk of atherothrombotic complications after percutaneous coronary intervention (PCI). In-stent restenosis (ISR) is a complication that limits the long-term prognosis of PCI. The aim was to investigate the association between presence of the CYP2C19*2 allele and ISR within one-year after PCI in patients prescribed dual antiplatelet therapy with aspirin and clopidogrel. METHODS: Sixty patients with angiographically-confirmed drug eluting stent (DES)-ISR within 12 months post-PCI when on DAPT with aspirin and clopidogrel were retrospectively identified (Cases). Another 60 patients with no documented ISR post-PCI in the study period (Controls) were case-matched for age, gender, ethnicity, diabetes mellitus and estimated glomerular filtration rate value, and were invited for CYP2C19*2 genotyping. The association between presence of the CYP2C19*2 allele and ISR was analysed using the Fisher's exact test and binary logistic regression. RESULTS: Twenty-six (43.3%) cases and 5 (8.3%) controls were carriers of one or two CYP2C19*2 alleles. As to non-carrier status of the CYP2C19*2 allele, 34 (56.7%) cases and 55 (91.7%) controls were identified. The association between CYP2C19*2 carrier status and DES-ISR within one-year post-PCI was statistically significant (p<0.001) in both the univariate and multivariate analysis. CONCLUSIONS: The proportion of patients who were carriers of one or two CYP2C19*2 alleles who presented with DES-ISR within one-year post-PCI while on clopidogrel was significantly higher compared to patients with no documented ISR.

A three-year post-graduate Doctorate in Pharmacy course incorporating professional, experiential and research activities: A collaborative innovative approach.

This article was migrated. The article was marked as recommended. Background A three-year post-graduate international Doctorate in Pharmacy collaborative course, was launched by the Department of Pharmacy, University of Malta in collaboration with the College of Pharmacy, University of Illinois at Chicago. Aim and rationale To demonstrate that the professional Doctorate in Pharmacy (i) fits the requirements of a Level 8 degree according to the Bologna process, (ii) helps graduates develop competencies and attributes in proficiency in clinical and professional aspects, (iii) has a research component that provides the right level of abilities to participate in research initiatives and to interpret research outcomes, (iv) enables graduates to obtain leadership characteristics. Approach The unique characteristics of the course were evaluated through an outcomes result-oriented measurement. Leadership aspects were measured through policies and strategies presented by students and graduates. Outcomes i) course is in line with the Bologna declaration, ii) research work shown in the dissertation satisfied competencies required iii) research abilities have been examined through a third party and found to be compliant with acquiring of concepts in the design, carrying out, assessment of outcomes and interpretation of results of the research study carried out by each student, and iv) leadership characteristics were shown by the positions taken up by the graduates and early outcomes from these positions. Conclusion Learning activities enable development of professionals able to merge scientific and practice aspects in the evaluation of innovative therapies, the use of medicines and patient monitoring, and in pharmaceutical policy development and regulation. Leadership positions taken up by graduates point to the acquisition of leadership skills by graduates. Next Steps The authors are happy to extend collaboration for this model to be adapted by other institutions for the curricular development entailed in this programme to enhance and improve an innovative aspect in the evolvement of the pharmacy profession on the international scenario.

Pharmacist-led medicine use review in community pharmacy for patients on warfarin.

Background Medicine use review by pharmacists has the potential to improve anticoagulation therapy management in patients on warfarin. Objective To develop, implement and evaluate a pharmacist-led medication use review service for patients on warfarin. Setting Six community pharmacies in Malta. Method Patients (N = 100) aged 18 or older and on warfarin were recruited through pre-selected community-pharmacies. These patients were then invited to attend two sessions: a review session (t1) and a follow-up session after 2 months (t2). During the medication use review session, medication reconciliation was performed (a) to detect drug-related problems using the DOCUMENT classification system, (b) to develop an individualised care plan for each patient and (c) to recommend an action for each identified problem for physician, pharmacist or patient consideration. At t2, the degree of acceptance of the recommendations was determined by assessing the number of drug-related problems for which action was taken to address the problem. International normalisation ration (INR) control was evaluated by calculating the percentage Time in Therapeutic Range (TTR) at t1 and t2 using the Rosendaal linear interpolation method. Main outcome measures Frequency and type of drug-related problems detected; percentage of accepted recommendations; and INR control. Results A total of 481 drug-related problems were identified; 40% (n = 190) were related to warfarin treatment. Need for monitoring (30%; n = 145), lack of compliance (20%; n = 97) and need for patient education (19%; n = 90) were the top three problems identified. There was a significant correlation between frequency of the problems and number of chronic medications (Spearman Correlation 0.583, p < 0.001), number of comorbidities (Spearman Correlation 0.327, p = 0.001) and older age (Spearman Correlation 0.285, p = 0.04). A total of 475 recommendations were followed-up; 49% (n = 234) were referred for consideration by the physician. The percentage of recommendations accepted (84%; n = 397) was significantly higher than the percentage of recommendations not accepted (16%; n = 78) (p < 0.001). The time in therapeutic range improved significantly from 68.7% at t1 to 79.8% at t2 (p = 0.01). Conclusions The high percentage of accepted recommendations and the improvement in INR control indicate that a pharmacist-led medication use review service in community pharmacy contributes to improving anticoagulation therapy management in patients on warfarin.

Clinical pharmacist implementation of a medication assessment tool for long-term management of atrial fibrillation in older persons.

BACKGROUND: Optimisation of drug therapy is important in the older population and may be facilitated by medication assessment tools (MATs). OBJECTIVE: The purpose of the study was to evaluate whether appropriateness of drug therapy and clinical pharmacist intervention documentation improved following implementation of a previously developed MAT for the long-term management of atrial fibrillation (MAT-AF). METHODS: Adherence to MAT-AF review criteria and clinical pharmacist intervention documentation was assessed by the researcher pre-MAT implementation in 150 patients aged ≥60 years admitted to a rehabilitation hospital with a diagnosis of atrial fibrillation. MAT-AF was introduced as a clinical tool in the hospital for identification of pharmaceutical care issues in atrial fibrillation patients. Adherence to MAT-AF and pharmacist intervention documentation were assessed by the researcher post-MAT implementation for a further 150 patients with the same inclusion criteria. Logistic regression analysis and measurement of odds ratio was used to identify differences in adherence to MAT-AF pre- and post-MAT implementation. The differences between two population proportions z-test was used to compare pharmacist intervention documentation pre- and post-MAT implementation. RESULTS: Adherence to MAT-AF criteria increased from 70.9% pre-implementation to 89.6% post-implementation. MAT-AF implementation resulted in a significant improvement in prescription of anticoagulant therapy (OR 4.07, p<0.001) and monitoring of laboratory parameters for digoxin (OR 10.40, p<0.001). Clinical pharmacist intervention documentation improved significantly post-implementation of MAT-AF (z-score 20.249, p<0.001). CONCLUSIONS: Implementation of MAT-AF within an interdisciplinary health care team significantly improved the appropriateness of drug therapy and pharmacist intervention documentation in older patients with atrial fibrillation.

Clinical pharmacist implementation of a medication assessment tool for long-term management of atrial fibrillation in older persons

Background: Optimisation of drug therapy is important in the older population and may be facilitated by medication assessment tools (MATs). Objective: The purpose of the study was to evaluate whether appropriateness of drug therapy and clinical pharmacist intervention documentation improved following implementation of a previously developed MAT for the long-term management of atrial fibrillation (MAT-AF). Methods: Adherence to MAT-AF review criteria and clinical pharmacist intervention documentation was assessed by the researcher pre-MAT implementation in 150 patients aged ≥60 years admitted to a rehabilitation hospital with a diagnosis of atrial fibrillation. MAT-AF was introduced as a clinical tool in the hospital for identification of pharmaceutical care issues in atrial fibrillation patients. Adherence to MAT-AF and pharmacist intervention documentation were assessed by the researcher post-MAT implementation for a further 150 patients with the same inclusion criteria. Logistic regression analysis and measurement of odds ratio was used to identify differences in adherence to MAT-AF pre- and post-MAT implementation. The differences between two population proportions z-test was used to compare pharmacist intervention documentation pre- and post-MAT implementation. Results: Adherence to MAT-AF criteria increased from 70.9% pre-implementation to 89.6% post-implementation. MAT-AF implementation resulted in a significant improvement in prescription of anticoagulant therapy (OR 4.07, p<0.001) and monitoring of laboratory parameters for digoxin (OR 10.40, p<0.001). Clinical pharmacist intervention documentation improved significantly post-implementation of MAT-AF (z-score 20.249, p<0.001). Conclusions: Implementation of MAT-AF within an interdisciplinary health care team significantly improved the appropriateness of drug therapy and pharmacist intervention documentation in older patients with atrial fibrillation

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Quality Issues Identified During the Evaluation of Biosimilars by the European Medicines Agency's Committee for Medicinal Products for Human Use.

The aim of this study was to identify trends in deficiencies raised during the EU evaluation of the quality part of dossiers for marketing authorisation applications of biosimilar medicinal products. All adopted day 120 list of questions on the quality module of 22 marketing authorisation applications for biosimilars submitted to the European Medicines Agency and concluded by the end of October 2015 was analysed. Frequencies of common deficiencies identified were calculated and summarised descriptions included. Frequencies and trends on quality deficiencies were recorded and presented for 22 biosimilar applications. Thirty-two 'major objections' for 9 products were identified from 14 marketing authorisation applications with 15 raised for drug substance and 17 for drug product. In addition, 547 'other concerns' for drug substance and 495 for drug product were also adopted. The frequencies and trends of the identified deficiencies together with their impact were discussed from a regulatory perspective and how these impact key manufacturing processes and key materials used in the production of biosimilars. This study provides an insight to the regulatory challenges prospective companies need to consider when developing biosimilars; it also helps elucidate common pitfalls in the development and production of biosimilars and in the submission of dossiers for their marketing authorisations. The results are expected to be of interest to pharmaceutical companies but also to regulators to obtain consistent information on medicinal products based on transparent rules safeguarding the necessary pharmaceutical quality of medicinal products.

Design and application of a medication assessment tool for secondary prevention of stroke.

Background Optimisation of drug therapy is essential in the care of older persons and may be facilitated by application of medication assessment tools (MATs). Objective To design, psychometrically evaluate and apply an innovative MAT for secondary prevention of ischaemic stroke with particular relevance to older persons. Method Review criteria were selected from clinical practice guidelines and MAT-CVA was developed, validated and tested for reliability and feasibility. MAT-CVA was applied to 150 patients with a diagnosis of ischaemic stroke or transient ischaemic attack admitted to a rehabilitation hospital. Results MAT-CVA consists of 17 criteria sectioned into antithrombotic, lipid lowering, antihypertensive and glycaemic therapy. Content validity was demonstrated for all criteria. Reliability was confirmed with kappa values of 0.80 for both inter- and intraobserver agreements. Mean application time for the two observers was 5.55 and 6.56 min. Adherence to applicable criteria was 55% and justified non-adherence was 22.3%. Non-adherence was predominantly evident for prescription of anticoagulation in concurrent atrial fibrillation (36.4%), thiazide diuretics ± angiotensin converting enzyme inhibitors for hypertension (26.8%) and dipyridamole at the recommended dose (24.0%). Conclusion Application of MAT-CVA indicated good overall adherence and identified gaps in clinical performance which may be targeted to enhance drug therapy optimisation.

Assessing appropriateness of drug therapy in older persons: Development and application of a medication assessment tool for long-term management of atrial fibrillation.

BACKGROUND: Atrial fibrillation (AF) is highly prevalent in older persons and is associated with considerable morbidity and mortality. Assessing appropriateness of drug therapy in AF may be facilitated by application of medication assessment tools (MATs). OBJECTIVE: To develop, psychometrically evaluate and apply an innovative MAT for the long-term management of AF with particular relevance to older persons. METHODS: Key recommendations from clinical practice guidelines for the long-term management of AF were selected and review criteria defining appropriate drug therapy were constructed as a 'qualifying statement' followed by a 'standard'. The developed MAT was given the designation MAT-AF. An application guide was compiled where justifications for non-adherence were specified. Content validity was tested by an expert group using a three-round Delphi process. Inter- and intra-observer reliability testing was conducted with agreement expressed by Cohen's kappa and application time measured to assess feasibility. MAT-AF was applied to 150 patients with a diagnosis of AF admitted to a rehabilitation hospital. RESULTS: MAT-AF consists of 15 criteria sectioned into antithrombotic, rate control and rhythm control therapy. Content validity was demonstrated for all criteria. Reliability was confirmed with kappa values of 0.84 and 0.91 for inter- and intra-observer agreements. Mean application time for the two observers was 3.9 and 2.4 minutes, which decreased significantly in the second application conducted after a four-week interval (p<0.001). Overall adherence to applicable criteria was 59.8%. Non-adherence was evident for prescription of anticoagulation in patients with a CHA2DS2VASc score ≥1 (29.5%). Monitoring of laboratory parameters for digoxin was suboptimal. Ophthalmic and pulmonary monitoring and patient counselling regarding amiodarone therapy could not be assessed since relevant records were not readily available. CONCLUSION: MAT-AF application highlighted key aspects which need to be addressed to improve patient care.

Comparison of a rapid point-of-care and two laboratory-based CYP2C19*2 genotyping assays for personalisation of antiplatelet therapy.

BACKGROUND: A quick CYP2C19*2 genotyping assay can be useful in personalised antiplatelet-therapy. OBJECTIVE: To apply a rapid point-of-care (POC) CYP2C19*2 genotyping assay for personalisation of antiplatelet therapy in patients undergoing percutaneous coronary intervention (PCI) and to compare this POC assay to two laboratory-based CYP2C19*2 genotyping assays. SETTING: Cardiac Catheterisation Suite and Molecular Diagnostics Unit in a general hospital. METHODS: A buccal sample was collected for POC CYP2C19*2 genotyping with the Spartan™ RX system (Spartan Bioscience). A whole blood sample was collected from the same patients for laboratory-based CYP2C19*2 genotyping with a TaqMan® allelic discrimination assay (Life Technologies) using real-time quantitative PCR and with the GenID® reverse dot-blot hybridisation assay (Autoimmun Diagnostika GmbH). Each patient was genotyped as a non-carrier of CYP2C19*2 (*1/*1), a carrier of one CYP2C19*2 allele (*1/*2), or a carrier of two CYP2C19*2 alleles (*2/*2). Genotyping, interpretation and communication of genotype results (*1/*2, *2/*2) to the consultant cardiologist was undertaken by a clinical pharmacist researcher. Quantitative and qualitative comparison between the three assays was carried out. MAIN OUTCOME MEASURES: Application of a rapid POC CYP2C19*2 genotyping assay for antiplatelet therapy individualisation; comparison of the POC CYP2C19*2 genotyping assay to two laboratory-based assays. RESULTS: The total sample consisted of 34 Caucasian patients. With the POC assay, 21 patients were genotyped as non-carriers of CYP2C19*2, 12 patients as carriers of one CYP2C19*2 allele and one patient as a carrier of two CYP2C19*2 alleles. With both laboratory-based assays, the same 21 patients were genotyped as non-carriers of CYP2C19*2, however 13 patients were genotyped as carriers of one CYP2C19*2 allele and no patients were genotyped as carriers of two CYP2C19*2 alleles. Agreement in genotype results was 97 % (κ = 0.939) between the POC assay and both laboratory-based assays and 100 % (κ = 1.000) between the two laboratory-based assays. CONCLUSION: Compared to both laboratory-based genotyping assays, the POC assay is accurate and reliable, provides rapid results, can process single samples, is portable and more operator-friendly, however the tests are more expensive.