Since 2001, EU rules have required the medicines we buy in the EU to contain a package leaflet which should provide us – the user, with clear information on the medicines we are taking – including the name of the product and the manufacturer, therapeutic indications, dosage, shelf life and adverse reactions.
The Commission has recently put forward recommendations on how they could be improved to better meet the needs of patients and healthcare professionals.
To read the recommendations on improved medicine packaging on the ec.europa.eu website
Pharmaceuticals in the environment represent a global pollution problem – over 631 different pharmaceutical agents (or their metabolites) have been detected in at least 71 countries covering all continents. Pharmaceutical residues have been detected in surface water, sewage effluents, groundwater, drinking water, manure, soil, and other environmental matrices. Antibiotics in the environment can promote the development of antibiotic-resistant pathogens – a major global health threat. Also, little is known about the effects on humans from continuous, long-term exposure to low concentrations of pharmaceuticals. Pharmaceutical substances are often engineered so
that they remain unchanged during their passage through the human body; unfortunately this stability means they also persist outside the human body and, as a consequence, can build up in the environment. Several studies have confirmed that medicines pose environmental risks, and that concentrations found in the environment can have detrimental effects on aquatic systems and wildlife.
The Dutch organisation – health care without harm Europe – has produced a report outlining what steps are being taken in Europe to reduce anti-microbial resistance (AMR) and offers opportunities for countries to work together on this shared problem.
All medicinal products in the EU are subject to a strict testing and assessment of their quality, efficacy and safety before being authorised. Once placed on the market they continue to be monitored to ensure that any aspect which could impact the safety profile of a medicine is detected and assessed and that necessary measures are taken. This monitoring is called pharmacovigilance.
Pharmacovigilance activities include:
- Collecting and managing data on the safety of medicines.
- Looking at the data to detect “signals” (any new or changing safety issue).
- Evaluating the data and making decisions with regard to safety issues.
- Pro-active risk management to minimise any potential risk associated with the use of the medicine.
- Acting to protect public health (including regulatory action).
- Communicating with and informing stakeholders and the public.
- Audit, both of the outcomes of action taken and of the key processes involved.
For more information about pharmacovigilance on the ec.europa.eu website
The proliferation of high-cost medicines and rising drug prices are increasing pressures on public health spending and calling into question the pharmaceutical industry’s pricing strategies.
According to a new report from the OECD, ‘ New Health Technologies: Managing Access, Value and Sustainability’, pharmaceutical spending is increasingly skewed towards high-cost products. The launch prices of drugs for cancer and rare diseases are rising, sometimes without a commensurate increase in health benefits for patients. For instance in the United States the launch price of oncology drugs per life-year gained has been multiplied by four in less than 20 years and now exceeds $200,000.
For more information on Pharmaceutical Price Rises on the oecd.org website
The UN European coalition on health is a coordination mechanism focusing on the achievement of Sustainable Development Goal (SDG) 3 – to ensure healthy lives and promote well-being for all at all ages – in the pan-European Region, and of the health-related targets present in other SDGs.
At its initial meeting in 2016 the coalition identified four key workstreams to focus on:
- health throughout the life-course, with a focus on maternal and child health (contributing to SDG 3, 4, 5, 16);
- communicable diseases, with a focus on HIV and tuberculosis (contributing to SDG 3, 1, 6);
- universal health coverage, with a focus on medicines (contributing to SDG 3, 1, 5);
- migration, including aspects of emergencies (contributing to SDG 3, 1, 10, 11, 13).
For more information about the UN European coalition on health on the euro.who.int website
The European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA) are developing scientific guidance to enable identification of endocrine disruptors.
In 2016 the European Commission proposed science-based criteria for identifying endocrine disruptors in the context of EU legislation on pesticides and biocides. Discussions with Member States and experts are on-going and the criteria are expected to enter into force in 2017.
EFSA and ECHA, supported by the Commission’s Joint Research Centre, will produce an outline of the guidance that will be published and will provide information on the drafting and endorsement processes.
For more information on endocrine disruptors on the efsa.europa.eu website
A new WHO report provides insight into how countries in the WHO European Region can improve access and reduce medicine prices through strategic and well-planned procurement processes. It also addresses collaboration within and across countries to improve availability of affordable medicines for patients in the Region.
Countries in the Region have varying capacity and negotiating power when it comes to procuring new medicines and health technologies. As a result, the prices that a given country is asked to pay for its medicines may be disproportionally high and incompatible with its purchasing power.
A study cited in the report illustrates this problem. It compares ex-factory prices of 2 new medicines used to treat hepatitis C – sofosbuvir and ledipasvir-sofosbuvir – and reveals that the cost of treating the entire hepatitis C-infected population in each of the 30 countries examined would range from 10.5% of the total pharmaceutical expenditure in the Netherlands to 190.5% in Poland. The price of a single course of sofosbuvir was equivalent to 5.28 years of the average annual wage in Turkey. The high price of ledipasvir-sofosbuvir in England led the National Health Service to restrict treatment to the most severely ill patients.
Download the report on Strategic Purchasing of Medicines from the euro.who.int website
Antibiotic resistance presents one of the biggest threats to global health and development today – and the threat is growing. On any given day, about 80,000 patients – or 1 in 18 patients in hospitals – in the EU have at least one health care associated infection according to estimates from the European Centre for Disease Prevention and Control (ECDC) and these are often difficult to treat because the microorganisms that cause them are resistant to antibiotics. These infections are estimated to result in 16 million extra days spent in hospital and 37,000 attributable deaths, as well as contributing to an additional 110,000 deaths a year. Annual financial losses are estimated at approximately €7 billion (direct costs only).
Health professionals – including general practitioners, nurses, hospital prescribers, dentists and pharmacists – can help prevent and control the spread of antibiotic resistance by following five key recommendations from WHO:
- if you think a patient might need antibiotics, where possible test to confirm and find out which one;
- only prescribe antibiotics when they are truly needed, according to current guidelines;
- prescribe and dispense the right antibiotic at the right dose for the right duration;
- prevent infections by using safe hygiene practices to ensure that your hands, instruments and environment are clean; and
- keep your patients’ vaccinations up to date.
For more information about Antibiotic resistance on the euro.who.int website
Do you have an interest in safe medicines for children – as a parent, researcher or prescriber? If so, you are invited to participate in a stakeholder consultation launched by the European Commission. The aim is to gather real-life experiences and opinions on the Paediatric Regulation which came into force a decade ago and has three main objectives:
- to ensure high-quality research into the development of medicines for children
- to ensure that the majority of medicines used by children are specifically authorised for such use and so reduce the level of off-label use
- to ensure the availability of high-quality information about medicines used by children.
The consultation is open until 20 February 2017.
More information about medicines for children and to contribute to the consultation on the ec.europa.eu website.
Monitoring the safety of medicines throughout their life cycle (pharmacovigilance) is the responsibility of the European Medicines Agency (EMA) on behalf of Member States. The European Commission has published a report, accompanied by a detailed Staff Working document, describing the activities of the collaborative EU system for monitoring and controlling the safety of human medicines.
The aim of EU rules on pharmacovigilance is to monitor the safety of medicines so that regulators can take action to reduce the risks and increase the benefits of medicines for human use. The role of individual EU countries is to monitor medicine safety data, assess signals of possible emerging side effects, and analyse the data when a safety issue is identified at European level. EMA has a central role in the EU system of pharmacovigilance as it coordinates the activities of an EU regulatory network of over 30 national competent authorities, and provides technical, regulatory and scientific support.
The report concludes that the European pharmacovigilance network is an example of successful cooperation at EU level which directly benefits patients. The networked system engages stakeholders (including healthcare professionals and patients) who can report suspected side effects directly. It operates with a high degree of transparency and ensures that EU medicines remain safe and effective and that accurate information on the safety of medicines reaches the public in a timely fashion.
Download the staff working document and report on pharmacovigilance from the ec.europa.eu website