New report ‘Patient Safety and Nanomedicines: the need for a centralised regulatory procedure’ calls to ensure patient safety through regulatory clarity
On World Patient Safety Day 2020, the European Alliance for Access to Safe Medicines along with several organisations launches its new report entitled “Patient Safety and Nanomedicines: the need for a centralised regulatory procedure”. Nanomedicines and their follow-on products, also referred to as nanosimilars, are complex molecules and so regulatory oversight must be scientifically fit for purpose.
Article in the highly subscribed EurActiv journal
Commission urged to consider common regulatory framework for nanomedicines” supports the EAASM goals for nanomedicines and nanosimilars for regulatory clarity
The lack of a fit-for-purpose regulatory framework on nanomedicines and their “generics” poses risks for the safety of EU patients and the European Commission should urgently look to address this, the Director of the European Alliance for Access to Safer Medicines (EAASM) stated.
New scientific paper: Patient safety issues associated with the use of compounded medicines as alternatives to approved pharmaceutical products in Europe and how best practice can improve outcomes
New Report Demonstrates Significant Resources Required to Implement FMD into Hospital Setting
Resources needed to implement the Falsified Medicines Directive in hospitals across the EU and the EEA would cost more than 86 million euros, according to estimates. The report extrapolates from data compiled on the volume of prescriptions dispensed within the hospital environment and provides a comprehensive analysis of potential solutions and next steps. Opportunities for the future emphasise ways in which medicine’s authentication systems (MAS) using artificial intelligence and automation can reduce the human resource required whilst delivering safer processes.
EAASM Co-ordinates multi-Stakeholder Article for Pharma Times
The upcoming Falsified Medicines Directive will only really succeed in increasing patient safety if all supply chain stakeholders grasp the opportunities that the legislation creates. The EAASM was excellently placed to bring together all of the major stakeholders and collate their views, in an article published by Pharma Times, which you can read here.
Costing the Earth report
The global criminal enterprise of falsified medicines has never had a higher profile. The purpose of this report is to show how costly this crime is to Society (both public and private). Although it is extremely difficult to calculate accurately the impact of an unseen criminal activity, ASOP EU took on this task.
The Costing the Earth report reviews key data relating to the criminal counterfeiting of medicines and attempts to quantify the cost to the various sectors from a global and European perspective.
Discounted or Dangerous?
The DoDs report is one of two reports the EAASM is publishing simultaneously. It highlights the abject standards in three member states where online pharmacy is supposedly not allowed (but seems rife) and the barely-better standards where the activity is legal. As an Alliance dedicated to patient safety, it would rather that it had not been necessary to undertake either of these projects, but the harsh reality is that much of Europe (and globally) the internet remains the pharmaceutical wildwest. The report, which you can read here, is a real eye opener.
Counterfeiting the Counterfeiter
This sister publication complements the DoD report and shows just how widespread counterfeit medicines are online, how easy it is to access them and how much money criminals can generate. The results are astounding with the fake website attracting in excess of 182,000 unique visitors. Of these over 12,000 decided to click through – having been exposed to a message about the dangers of buying medicines online – se are questions that are often asked and that often go unanswered. Now, the EAASM, in its most ambitious project to date, uncovers the reality. Counterfeiting the Counterfeiter is a remarkable story and you can read it here.
Packaging Patient Protection
The European Alliance for Access to Safe Medicines (EAASM) submitted a report to European Parliament, calling for enhanced legislation to improve the protection of Europe’s patients against the intensifying risks and dangers of counterfeit medicines.
Packaging Patient Protection, published by the EAASM in partnership with stakeholders in patient associations, non-governmental organisations and the pharmaceutical industry, is a clear set of recommendations for new laws to combat fake, counterfeit and substandard medicines.
The document delivers seven key recommendations for Europe’s policy-makers, including:
- a legal obligation for any party in the supply chain unpacking a medicine box to (re)apply a minimum level of effective traceable and tamper-proof security technology
- a mechanism to ensure that cost should not, as far as possible, be a prohibitive in the implementation of a universally-supported minimum security provision; however, original manufacturers may choose to supplement this with additional overt or covert security features on particular products
- a means by which patient in Europe may recognise medicines that have been tampered with since issue from the original manufacturer
The Counterfeiting Superhighway – the growing threat of online pharmacies (June 2008)
There has been an explosion in the number of counterfeit medicines reaching patients in recent years – one reason for this is the increase in illegal online pharmacies.
Scope of this report
Untrained, unsuspecting consumers are vulnerable to the potentially lethal outcomes of buying medicines online. The Counterfeiting Superhighway reveals the scope and repercussions of this dangerous practice through extensive research and examination of over 100 online pharmacies and over 30 commonly purchased prescription-only medicines. These include medicines indicated to treat serious conditions such as cardiovascular and respiratory disease, neurological disorders, and mental health conditions).
Key findings from this report
- 62% of medicines purchased online are fake or substandard
- 95.6% of online pharmacies researched are operating illegally.
- 94% of websites do not have a named, verifiable pharmacist.
- Over 90% of websites supply prescription-only medicines without a prescription.
The report concludes by providing recommendations
Based on the research findings and calls all stakeholders including search engines, credit card companies, shipping companies, patient groups and regulators, to take action and halt this dangerous trend.
European Patient Safety and Parallel Pharmaceutical Trade – a potential public health disaster? (November 2007)
The European pharmaceutical market could be heading towards a public health disaster with respect to distribution chain regulation and supply chain security.
Scope of this report
The compelling report by Dr Jonathan Harper distils and analyses available studies, and examines the economic issues around parallel pharmaceutical trade (PPT). The report looks at how the right of every patient to expect safe medicines can best be respected.
Key reasons to read this report
To date, the main academic and policy arguments have focused on the economic issues of PPT. Dr Harper’s report provides analysis of the topic in a broader context, which involves a number of factors in addition to pure health economics.