Anthony Serracino-Inglott

Consumer perception of the community pharmacist and community pharmacy services in Malta

Objectives  We aimed to determine the perception of Maltese consumers of the community pharmacist and of the services offered from community pharmacies.

A simple HPLC-UV method for the determination of ciprofloxacin in human plasma

A rapid and sensitive HPLC-UV method for the determination of ciprofloxacin in human plasma is described. Protein precipitation with acetonitrile was used to separate the drug from plasma protein. An ACE(®) 5 C18 column (250 mm×4.6 mm, 5 μm) with an isocratic mobile phase consisting of phosphate buffer (pH 2.7) and acetonitrile (77:23, v/v) was used for separation. The UV detector was set at 277 nm. The method was validated in the linear range of 0.05-8 μg/ml with acceptable inter- and intra-assay precision, accuracy and stability. The method is simple and rapid and can be used to quantify this widely used antibiotic in the plasma of patients suffering from Peripheral Arterial Disease.

European Union pharmacovigilance capabilities: potential for the new legislation.

European Directives and Regulations introduced between late 2010 and 2012 have substantially overhauled pharmacovigilance processes across the European Union (EU). In this review, the implementation of the pharmacovigilance legislative framework by EU regulators is examined with the aim of mapping Directive 2010/84/EU and Regulation EC No. 1235/2010 against their aspired objectives of strengthening and rationalizing pharmacovigilance in the EU. A comprehensive review of the current state of affairs of the progress made by EU regulators is presented in this paper. Our review shows that intense efforts by regulators and industry to fulfil legislative obligations have resulted in major positive shifts in pharmacovigilance. Harmonized decision making, transparency in decision processes with patient involvement, information accessibility to the public, patient adverse drug reaction reporting, efforts in communication and enhanced cooperation between member states to maximize resource utilization and minimize duplication of efforts are observed.

Time and motion study for pharmacists' activities in a geriatric hospital

Objectives This study aimed to identify and quantify activities undertaken by pharmacists in a geriatric hospital.

Attitudes towards preconception care in Maltese women with type 1 diabetes mellitus.

Introduction: The aim of this study was to assess the level of knowledge and awareness related to preconception care among Maltese women of reproductive age with type 1 diabetes mellitus (T1DM). Methods: Thirty-seven T1DM women, aged 12–30 years, were self-administered a questionnaire related to diabetes self-management and preconception care. The participants then underwent an educational intervention and re-took the same questionnaire. Results: Before the intervention, 26 participants (70%) claimed they did not have any knowledge about the preconception care of diabetes. Of the remaining 11 participants, the main reported source of information about diabetes care was the diabetologist (n = 8; 6.7%). The response rate was 70% (26 out of 37 participants completed the questionnaire after the educational intervention). Six of the participants who initially reported no preconception care knowledge claimed an increased awareness after the event. There was a statistically significant increase in the knowledge scores after the intervention. Conclusion: It is evident that there is a lack of awareness of the importance of pre-pregnancy planning to avoid pregnancy-related complications with diabetes. This emphasizes the need for more education and it is imperative for healthcare professionals to address these issues with adolescent female patients.

Factors Affecting Penetration of Ciprofloxacin in Lower Extremity Ischemic Tissues

The aims of this study were to evaluate factors influencing the distribution of ciprofloxacin in tissue of patients suffering from varying degrees of peripheral arterial disease (PAD). Blood and tissue samples were collected from patients undergoing debridement or amputation procedures and the amount of ciprofloxacin in them was determined using high-performance liquid chromatography. All patients were administered a 200-mg dose of intravenous ciprofloxacin prior to the debridement or amputation procedure. Data, including patient gender, age, type of diabetes, presence of neuropathy, medications taken, and severity of PAD were collected. These data were then analyzed to determine factors influencing the concentrations of ciprofloxacin in tissue of the lower limbs. The Kruskal-Wallis test, Spearman correlation, and chi-square test were used to relate covariates and fixed factors with the concentration of ciprofloxacin in tissue. Following bivariate analysis, a 3-predictor regression model was fitted to predict tissue concentrations of ciprofloxacin given information about these predictors. Blood and tissue samples were collected from 50 patients having an average age of 68 years. Thirty-three patients were males and 35 patients suffered from type 2 diabetes. The average number of medications that these patients were taking was 10. The majority of patients (n = 35) were suffering from severe PAD. Tissue concentrations of ciprofloxacin were mainly related to plasma concentrations of ciprofloxacin, number of medications that the patients were taking and severity of PAD.

Multimodal management as requirement for the clinical use of anticachexia drugs - a regulatory and a clinical perspective.

Purpose of reviewMultimodal management has been proposed as key to any effective drug intervention in cachexia. This article attempts to reflect on clinical and regulatory considerations of multimodal management treatment as a regulatory requirement in anticachexia drug therapy. To date, no European Union (EU) regulatory guidelines have been published and therefore this review could attempt to present and discuss some central issues to consider when developing an anticachexia drug. Recent findingsThe following themes are considered: EU regulatory pathways for drug approval (conditional and exceptional circumstances as well as adaptive licensing); selection criteria for randomized clinical trials allowing the identification and characterization of the population of interest that is an at-risk population with undisputable clinical need; issues related to primary and secondary outcome measures that are adequate to determine the efficacy of the intervention and the approach for the development of clinical biomarkers for cachexia. SummaryConversely, the incorporation of multimodal treatment in anticachexia drug therapy is expected to increase the effectiveness of intervention. This aspect is the aspect that appeals to pharmaceutical companies; however, at the same time, this raises regulatory and clinical issues that need to be kept in mind when designing randomised clinical trials.

Standardising pharmacist patient-profiling activities in a rehabilitation hospital in Malta

Objectives To develop, validate, test for applicability and practicality, implement and undertake a preliminary evaluation of a standard operating procedure (SOP) for pharmacist patient-profiling activities at Rehabilitation Hospital Karin Grech (RHKG). Methods Following direct observation of pharmacist patient-profiling activities in the hospital, a draft SOP was developed. The SOP was validated twice using a self-administered validation questionnaire and was amended according to suggestions proposed during validation. The validated SOP was tested for applicability and practicality through an observation study. Pharmacists were trained to follow the SOP correctly and the SOP was subsequently implemented. Preliminary evaluation of the SOP was undertaken using a self-administered evaluation questionnaire 1 and 4 months post implementation. Results A ‘patient-profiling’ SOP for pharmacists was developed. Validation was beneficial since constructive suggestions were proposed and improvements with respect to SOP content, length, presentation, layout and comprehensiveness were implemented to develop the final version of the SOP. The SOP was found to be practical and applicable for use at RHKG. Preliminary evaluation showed that all pharmacists (nine) found the SOP fit for purpose, easy to follow for training new pharmacists, user friendly, easy to understand and promotes consistency in patient-profiling activities. Conclusions The ‘patient-profiling’ SOP provides a comprehensive approach to standardisation of pharmacist patient-profiling activities at RHKG to improve the quality of patient care. The SOP will need to be regularly reviewed and updated and can be transferred to other hospital settings with minor amendments.

Point-of-Care Testing for Urine Analysis and Microalbuminuria for Diabetic Patient Management:

AbstractThe objective was to implement point-of-care testing in the community pharmacy setting for the urine analysis of microalbuminuria and study the accuracy, practicality, and feasibility of the service. Three community pharmacies in Malta were used to randomly recruit 25 type 1 or 2 diabetic ad

Could EU herbal monographs contribute to Malta's treatment armamentarium?

Ten years have passed since Directive 2004/24/EC regulating herbal medicinal products across the EU were published. The directive created the Committee on Herbal Medicinal Products within the European Medicines Agency whose remit includes the creation and publishing of official EU monographs on herbal medicinal products. These monographs include the official uses of the products and their evidence for efficacy and safety. To this effect, we are interested in analysing the potential impact herbal product EU monographs could have on the therapeutic treatment options available for prescribers in Malta. Therefore our aim was two-fold. First, to rationalise the spread of indications of the herbal substances listed in the community herbal monograph inventory and subsequently determine if these herbal substances could potentially contribute to the treatment options available in our local scenario (Malta). 128 EU monographs were analysed resulting in a total of 230 indications which subsequently codified into 42 unique ATC codes. The Malta Medicines List contains 1456 unique ATC codes. Comparative analysis of the Malta Medicines List revealed that the 21 therapeutic areas had 4 or less pharmaceutically used substances (5th level ATC codes) registered and therefore in our opinion are areas with limited therapeutic choice. The following 4 therapeutic areas, A05 bile and liver therapy, A13 tonics, A15 appetite stimulants and D03 preparations for treatment of wounds and ulcers, could potentially benefit from the registration of herbal medicinal products according to the EU herbal monographs. If such registration is effected the aforementioned areas would no longer be considered limited because more than 4 therapeutic choices would be available to prescribers. This study is the first study across the EU to analyse the potential impact of published EU herbal monographs on therapeutic coverage in an EU member state and confirms the notion that herbal products could potentially increase the treatment options available in areas where few medical products have been registered due to Maltas small market size.