Overview of the Workshop ”OTC medicines: the role of good classification practices in promoting medication safety and accessibility in Europe”
04.12.2014
An expert workshop "OTC medicines: the role of good classification in promoting medication safety and accessibility in Europe” organised by the Council of Europe’s European Directorate for the Quality of Medicines and Healthcare (EDQM) and the Agency for Medicinal Products and Medical Devices (HALMED) was held from 20 to 21 November 2014 in Zagreb. Nearly 100 participants from 19 countries in Europe, representing national and European competent drug authorities, ministries of health, healthcare professionals, patients’ organisations, the pharmaceutical industry and pharmaceutical wholesalers involved in classification of medicines as regard their supply.
Welcome speeches were held by Susanne Keitel, PhD, the Director of EDQM, Viola Macolić Šarinić, MD, PhD, the Head of HALMED and chair of the EDQM’s Committee of Experts on the Classification of Medicines as Regards their Supply (CD-P-PH/PHO).
The classification of medicines as regards their supply has implications on patient safety, accessibility of medicines to patients and responsible management of health care expenditure. The decision on the prescription status related supply conditions is a core competency of national health authorities. Taking account that important additional classification criteria are not harmonised and there are wide disparities in European countries, European harmonisation is on-going to address this.
The workshop was aimed at providing extended knowledge to participants and to familiarise them with the work of the Committee of Experts on the Classification of Medicines as regards their Supply (CD-P-PH/PHO), which annually issues recommendations to health authorities of European Pharmacopoeia member states for the classification of medicines and establishes good classification practices, and to collect feedback from the different stakeholders, including patient associations. The working programme of the CD-P-PH/PHO is coordinated by the EDQM and is based on Council of Europe Committee of Ministers Resolution ResAP(2007) on the classification of medicines as regards their supply.
The first part of the conference was focused on raising awareness, education and patient’s health literacy o the safe and adequate use of OTC medicines. In this part, Zaide Frias from the European Medicine’s Agency (EMA) talked about regulatory approaches in this area, and Gerald Dziekan from the World Self-Medication Industry presented the industry’s position. Miroslav Hanževački from the Health Centre Zagreb-West talked on behalf of healthcare professionals, whereas Tihana Kreso from the Croatian Alliance for Rare Diseases presented patients’ position. The plenary session was followed by discussions on regulatory, scientific-industrial and social dimensions of these topics.
The second part was focused on distant trade of medicinal products and new modes of medicinal products’ distribution. In this part the legal framework was presented by Escribano Romero from the Spanish Medicines Agency (AEMPS) and the representative of the Italian Medicines Agency (AIFA), Marcello Chiavoni who especially highlighted the problem of counterfeit medicines. . Klaus Gritschneder from the European Association of Mail Services Pharmacies (EAMSP) held a lecture on mail ordering of medicines and cross-border and online sales of medicines, and the patients’ position was presented by Joanna Groves from the International Alliance of Patients’ Organisations (IAPO). Presentations were followed by discussions on these topics from legal, regulatory and social aspects.
The third part of the workshop was focused on regulation possibilities of dispensing OTC medicines in "Pharmacy Only” and "General Sales”. The regulatory framework was presented by Amanda Williams from the UK’s Medicines and Healthcare Products Regulatory Agency. The industry’s position was presented by Hubertus Cranz from the Association of the European Self-Medication Industry (AESGP), and John Chave from the Pharmaceutical Group of the EU (PGEU) talked on behalf of healthcare professionals. Patients’ position was also presented by Ivica Belina from the Coordination of Associations in Health (KUZ), whereas distributers’ positions were presented by the European Association of Pharmaceutical Full-line Wholesalers (GIRP), Monika Derecque-Pois. The plenary session was followed by discussions on these topics from legal, regulatory and social aspects.
With this workshop, all stakeholders demonstrated readiness for common action in order to harmonise the OTC classification and to promote safe and accessible medicines for European patients. The overview of the Croatian Pharmaceutical society on the workshop "OTC medicines: the role of good classification practices in promoting medication safety and accessibility in Europe” may be found here.
