Designing a national combined reporting form for adverse drug reactions and medication errors.

The Maltese Medicines Authority was tasked with developing a reporting form that captures high-quality case information on adverse drug reactions (ADRs) and medication errors in order to fulfil its public-health obligations set by the European Union (EU) legislation on pharmacovigilance. This paper describes the process of introducing the first combined ADR/medication error reporting form in the EU for health-care professionals, the analysis of reports generated by it and the promotion of the system. A review of existing ADR forms was carried out and recommendations from the European Medicines Agency and World Health Organization audits integrated. A new, combined ADR/medication error reporting form was developed and pilot tested based on case studies. The Authority's quality system (ISO 9001 certified) was redesigned and a promotion strategy was deployed. The process used in Malta can be useful for countries that need to develop systems relative to ADR/medication error reporting and to improve the quality of data capture within their systems.

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 Malta's small market size.

Designing a national combined reporting form for adverse drug reactions and medication errors

تم تكليف هيئة الأدوية المالطية بإعداد استمارة إبلاغ تلتقط معلومات عالية الجودة عن حالات التفاعات الدوائية الضارة وأخطاء المداواة لكي تفي الهيئة بالتزاماتها في مجال الصحة العامة التي حددتها تشريعات الاتحاد الأوروبي بخصوص التيقظ الدوائي. ويقدِّم هذا البحث وصفاً لعملية تقديم أول استمارة إباغ مشركة عن التفاعات الدوائية الضارة وأخطاء المداواة في الاتحاد الأوروبي للعاملن في مجال الرعاية الصحية، ولتحليل التقارير الناتجة عنها، ولتعزيز النظام الصحي. تم القيام بمراجعة الاستمارات الحالية الخاصة بالتفاعات الدوائية الضارة وإدراج التوصيات الصادرة عن عمليات التدقيق التي قامت بها وكالة الأدويةالأوروبية ومنظمة الصحة العالمية. ومن ثمّ تم إعداد استمارة جديدة مشركة للإباغ عن التفاعات الدوائية الضارة وأخطاء المداواة، وتم اختبارهاتجريبياً استناداً إلى دراسات حالات. وأعيد تصميم نظام جودة الهيئة إيزو 9001 المعتمد، ثم نظمت اسراتيجية ترويجية. إن الطريقة التي استخدمت في مالطا يمكن أن تفيد البلدان التي تحتاج إلى إعداد نظم تتعلق بالإباغ عن التفاعات الدوائية الضارة وأخطاء المداواة، وإلى تحسن جودة التقاط البيانات داخل نظمها

The Maltese Medicines Authority was tasked with developing a reporting form that captures highquality case information on adverse drug reactions (ADRs) and medication errors in order to fulfil its public-health obligations set by the European Union (EU) legislation on pharmacovigilance. This paper describes the processof introducing the first combined ADR/medication error reporting form in the EU for health-care professionals, the analysis of reports generated by it and the promotion of the system. A review of existing ADR forms was carried out and recommendations from the European Medicines Agency and World Health Organization auditsintegrated. A new, combined ADR/medication error reporting form was developed and pilot tested based on case studies. The Authority’s quality system (ISO 9001 certified) was redesigned and a promotion strategy was deployed. The process used in Malta can be useful for countries that need to develop systems relative to ADR/medication error reporting and to improve the quality of data capture within their systems.

L'Autorité maltaise pour les médicaments (Maltese Medicines Authority) a été chargée d'élaborer un formulaire de notification visant à recueillir des informations de haute qualité sur les réactions indésirables aux médicaments et les erreurs de médication afin de satisfaire à ses obligations de santé publique définies par lalégislation de l'Union européenne sur la pharmacovigilance. Le présent article décrit le processus d'introduction du premier formulaire de notification combinant les réactions indésirables aux médicaments et les erreurs de médication pour les professionnels des soins de santé dans l'Union européenne, l'analyse des rapportsissus de ce processus et la promotion de ce système. Les formulaires de notification des réactions indésirables aux médicaments existants ont été passés en revue et les recommandations de l'Agence européenne des médicaments ainsi que des audits de l'Organisation mondiale de la Santé ont été intégrés. Un nouveau formulairede notification combinant les réactions indésirables aux médicaments et les erreurs de médication a été élaboré puis soumis à un essai pilote dans des études de cas. Le système qualité de l'Autorité maltaise (certifié ISO 9001) a été remanié et une stratégie de promotion a été déployée. Le processus appliqué à Malte peut être utile à d'autres pays qui ont besoin de mettre au point des systèmes de notification des réactions indésirables aux médicaments et des erreurs de médication et souhaitent améliorer la qualité du` recueil des données au sein de leurs systèmes.

Actions of pyrethroid insecticides on sodium currents, action potentials, and contractile rhythm in isolated mammalian ventricular myocytes and perfused hearts.

Pyrethroid insecticides are known to modify neuronal sodium channels, inducing persistent, steady-state sodium current at depolarized membrane potentials. Cardiac myocytes are also rich in sodium channels but comparatively little is known about the effect of pyrethroids on the heart, or on the cardiac sodium channel isoform. In the present study therefore, we determined the actions of type I and type II pyrethroids against rat and guinea pig ventricular myocytes under current and voltage clamp, and on isolated perfused rat hearts. In myocytes, tefluthrin (type I) and fenpropathrin and alpha-cypermethrin (type II) prolonged action potentials and evoked afterdepolarizations. The time course of sodium current (I(Na)) was also prolonged by these compounds. Pyrethroids delayed I(Na) inactivation, when measured under selective conditions as current sensitive to 30 microM tetrodotoxin, by increasing the proportion of slowly inactivating current at the expense of fast inactivating current. Further experiments, focusing on fenpropathrin, revealed that its effects on I(Na) inactivation time course were dose-dependent, and the Na(+) "window-current" was increased in its presence. In unstimulated, isolated hearts perfused with the same pyrethroids, the variability in contraction amplitude increased due to variations in the intervals between heartbeats. These potentially arrhythmogenic changes are consistent with the effects observed at the cellular level. The type I pyrethroid tetramethrin had little effect in any of the preparations. These findings suggest that some pyrethroids possess considerable mammalian cardiac arrhythmogenic potential, the manifestation of which in vivo may depend on the route of exposure.