The Danish Medicines Agency's pharmacovigilance strategy 2017-2021
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REVISED IN DECEMBER 2018 The Danish Medicines Agency’s pharmacovigilance strategy 2017-2021
© Danish Medicines Agency, 2018. This publication may be freely quoted with appropriate acknowledgement of the source. Images from this publication must not be reused. Danish Medicines Agency Axel Heides Gade 1 2300 Copenhagen S Denmark dkma.dk Version 2.0 Version date December 2018
1
Introduction
Our mission
Effective, safe and accessible medicines and safe medical devices that benefit society
Our vision
The Danish Medicines Agency: Among Europe’s best in class
This means
Active dialogue and collaboration – value to citizens
Quality and on-time delivery
Professional expertise and commitment – a fantastic place to work!
Help boost Denmark as a leading life science nation
Driver of European collaboration and a strong international position
Our culture and values support and guide our employees towards becoming Europe's best in
class. Through collaboration, our performance and improvement culture allows us to
consistently pursue our guiding values; and to be attentive, professional, efficient and
European.
Our overall strategy for 2017-2021 and underlying sub-strategies describe how we will
become part of Europe’s best in class.
Our goal of reaching a European best-in-class level is in many areas achieved through
consolidation. It includes timely national assessment times, control and inspections at a level
matching our risk-based approaches, full compliance with the pharmacovigilance standards
as well as modernisation and simplification of our IT landscape. As 2018 comes to an end, we
have come far with this consolidation.
The pharmacovigilance strategy contributes to this work and is revised on an annual basis to
ensure it is up to date. This present version has been updated at the end of 2018.
Brexit will have an impact on all our specific strategies, including the pharmacovigilance area.
The Danish Medicines Agency has already taken over a number of European
pharmacovigilance tasks from the UK, and regardless of the Brexit outcome, the Danish
Medicines Agency will continue to receive an additional number of pharmacovigilance-related
activities and responsibilities.
The Danish Medicines Agency’s pharmacovigilance strategy 2017-2021 32 About pharmacovigilance and the tasks of the Danish Medicines Agency When a new medicine is authorised and marketed, it has been tested in a defined and well- controlled group of people. The medicinal product’s effects and most common adverse reactions are therefore known. To ensure patient safety, knowledge of the medicinal product’s safety profile is decisive after the product has come into use. We obtain this knowledge by monitoring the adverse reactions that users experience or otherwise become known to us. The Danish Medicines Agency is responsible for monitoring the safety of medicinal products in Denmark. In accordance with the Danish Medicines Act, we must operate a pharmacovigilance system for this purpose, keep records of reported adverse reactions 1 as well as analyse and take appropriate action on this information. In July 2012, the EU introduced new stricter rules on the monitoring of medicinal products for human use. This led to a procedure for common single assessment of Periodic Safety Update Reports for medicinal products (PSUR). As regards medicinal products containing the same active substance or the same combination of active substances, the European Medicines Agency (EMA) has introduced new safety referral procedures. Moreover, the Danish Medicines Agency and the other national competent authorities are required to collaborate with the EMA on the monitoring of data about medicinal products for human use in the European database of adverse reactions: EudraVigilance. The purpose of this collaboration is to detect any new or changed risks that may affect the risk-benefit balance of medicinal products (signal detections)2. As regards centrally authorised medicinal products for human use, the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Human Medicinal Products (CHMP) are responsible for monitoring the safety of human medicines. Regarding non- centrally authorised medicinal products, the PRAC and the CHMP collaborate with the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh). The Danish Medicines Agency participates in a number of relevant EU forums. 1 The rules governing the reporting of adverse reactions from medicinal products for human use and veterinary use to the Danish Medicines Agency are laid down in the Danish executive order no. 1823 of 15 December 2015 on the reporting of adverse reactions from medicinal products etc. and the Danish executive order no. 898 of 23 June 2016 on monitoring of adverse reactions from medicinal products. 2 See article 107h(1)(c) of Directive 2001/83/EC on the community code relating to medicinal products for human use as amended by Directive 2010/84/EU. The Danish Medicines Agency’s pharmacovigilance strategy 2017-2021 4
3 Strategic challenges Our vision of becoming part of Europe’s best in class places more stringent requirements on our work in several areas, including efforts to enhance the safety of medicinal products in a national and international perspective. The most important efforts are described below. The stakeholders around us have clear expectations that we, as an authority, detect all potential ADR signals based on the available knowledge, via reporting systems and interaction with collaboration partners. As part of the national and international health policy agendas to strengthen patient safety and provide a more patient-centred health service, the end users are expected to be involved and consulted in relation to solutions, if relevant. In order to strengthen patient safety, we will work efficiently and adopt a risk-based approach to be able to identify any problems quickly. This should be accompanied by timely information on safety issues and any measures to reduce risks. Evaluation of the impact of risk minimisation efforts is an integrated part of pharmacovigilance in the EU. Member states are expected to initiate relevant risk minimisation efforts and to evaluate the outcome of these efforts. Important knowledge and relevant data about potential adverse reactions and safety issues are available in several places, including the health service, industry, research environments and among medicine users. The number of data sources that can contribute to knowledge about new potential safety problems is expected to increase due to for instance increased digitisation. At present, we have no overall knowledge of the data sources that may be used to monitor the safety of marketed medicinal products. In addition, we lack an overview of the stakeholders that should be informed and involved in the monitoring, and that we can use as a basis for targeted communication and follow-up. Efficient analysis of possible safety issues requires a common understanding and common control tools. This is important as a basis for prioritising present information, selecting analytical method, and measuring the effect of pharmacovigilance. Below the Danish Medicines Agency’s most important strategic challenges within pharmacovigilance are outlined in relation to external requirements in a number of areas, such as our collection and use of data and our communication of safety problems. Moreover, the figure shows the requirements for our internal and external collaboration if we are to select optimal data sources, analyse data in the best possible way, provide targeted communication to citizens and healthcare professionals and evaluate the effect of our communication. The Danish Medicines Agency’s pharmacovigilance strategy 2017-2021 5
We will ensure the best possible safety of medicines through intensified pharmacovigilance. We aim for a leading position in Europe and want to influence the European standard for pharmacovigilance. Improved signal evaluation, systematic risk analysis, effective risk minimisation efforts, and new partnerships are our key initiatives in the coming years. 4 Objectives and focus areas 4.1 Close dialogue and collaboration in Denmark In the year 2021, we have a close and active dialogue with users of medicinal products, the health service and companies. We want to be an active collaboration partner and communicator in the mandatory collaboration between authorities in order to strengthen patient safety. To fulfil our pharmacovigilance responsibilities, we have established collaboration forums and dialogue meetings with relevant external stakeholders, including the pharmaceutical industry, the health service and patient organisations that work together to find common solutions to enhance patient safety. We have also set up formal partnerships with relevant Danish authorities. We work continuously to enhance the IT infrastructure for reporting and monitoring of adverse reactions in collaboration with relevant partners. We want to be more visible at national conferences, communicate in Danish journals, arrange meetings targeted at relevant stakeholders and encourage the strengthening of the collaboration with research and development environments. The Danish Medicines Agency’s pharmacovigilance strategy 2017-2021 6
4.2 In the forefront internationally and in the EU In the year 2021, we are in the forefront in the EU collaboration on pharmacovigilance and a key driver in selected areas. To reach this target, we will increase our commitment and take leadership where possible in the European collaboration. We want to strengthen our influence in the EU by contributing to pan-European knowledge sharing, by achieving more rapporteurships in the EU’s Pharmacovigilance Risk Assessment Committee, PRAC, and by participating in relevant EMA working groups, including ensuring a high quality of the data held in the common European adverse reaction database, EudraVigilance. We want Denmark to assert itself on selected areas of pharmacovigilance. We will also seek to share experience with other international authorities and strengthen the bilateral collaborations, also outside the EU. On the international scene, we will position and highlight the Danish efforts by being visible and active communicators at important conferences. 4.3 Ensuring and enhancing a robust data basis for signal analysis and risk minimisation In the year 2021, we have obtained structured and adequate data of a high quality based on all relevant sources to ensure fast and efficient analysis of signals. To reach this target, we will map data sources and players (internally and externally) and prioritise the sources that the Danish Medicines Agency will use. We will optimise the access to and use of data for signal generation as well as evaluate and validate risk minimisation efforts where the risks are highest. We will proactively and in partnership with Danish pharmacoepidemiological research environments exploit the potential of the Danish registries. We will ensure a continuous, functional database and analysis tool for Danish ADR reports. We will establish methods for the monitoring of the results of risk minimisation efforts launched by the pharmaceutical companies and by us. We will investigate practices in other countries and form partnerships with our colleagues in the European and international network of agencies to establish efficient methods and tools to follow up and measure the effect of risk minimisation efforts. We will work towards a pan- European approach. The Danish Medicines Agency’s pharmacovigilance strategy 2017-2021 7
4.4 Efficient pharmacovigilance
In the year 2021, Denmark is a pioneer in pharmacovigilance.
With LEAN as our management tool, we continue to work determinedly with task prioritisation
and will ensure a high focus on our key deliveries through dynamic and efficient resource
allocation. Through a risk-based, systematic and targeted approach, we will work with
continuous improvements in mind and constantly look for better and smarter ways of working
so we can dedicate more of our time to realise our vision to become Europe's best in class.
We have adopted a matrix approach to ensure relevant and efficient operations across the
Danish Medicines Agency. Through specialised competence teams, we ensure the best
possible use of our combined resources through which we strengthen collaboration,
development and knowledge sharing.
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Overall delivery plan in the strategy period
The objectives and focus areas of the strategy build on the present pharmacovigilance
approach and, when put into practice, it will be a major step towards realising our vision of a
leading position in Europe.
Our most important deliveries in the strategy period are to:
map our most important stakeholders in relation to pharmacovigilance and
communication as well as include the stakeholders in new partnerships
select and commit ourselves to relevant working parties and areas in the EMA and the
EU
ensure the continuous operation of a functional database of adverse reactions as well as
a user-friendly recording of Danish adverse reaction reports
develop and implement a system for task prioritisation (LEAN)
work strategically with new data sources, including partnerships with Danish
pharmacoepidemiological research environments on the use of registry data and other
sources of big data
evaluate safety issues and risk minimisation efforts continuously and systematically
communicate important safety information in a timely manner through the right channels
targeting the recipient
The implementation of the above focus areas will be an ambitious quality boost and will
improve pharmacovigilance substantially for the benefit of user safety. The
pharmacovigilance strategy will be translated into local action plans annually.
The Danish Medicines Agency’s pharmacovigilance strategy 2017-2021 8Specific efforts in 2019
Launching a new process for dissemination of safety information to healthcare
professionals
Expanding the dialogue with stakeholder groups to comprise also dentists and
pharmacists
Expanding our international collaborations in selected areas
Increasing our active participation in PRAC meetings.
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