13 Oct Hospitals Protecting Themselves Against Falsified Healthcare Products
Authors: Mrs Els van der Wilden, MD, MPH, Director Healthcare Providers, GS1; Mr Jean-Michel Descoutures, Pharmacist – RESAH Medication Coordinator, Victor Dupouy Hospital
In healthcare, quality of services and products is crucial. If not properly secured, falsified products can enter the healthcare supply chain and interfere with patient care delivery. More and more, governments and regulators worldwide acknowledge the need to fight falsification and have adopted or developed healthcare products identification and traceability systems.
Therefore, regulations around the world mandate manufacturers to globally uniquely identify and mark medical products (both pharmaceuticals and medical devices). However, hospitals and health systems are not always aware of the benefits these ‘barcodes on the products’ can bring to their work. For instance, in the European Union, the Falsified Medicines Directive (EU FMD) might be seen as extra burden in the delivery of pharmaceutical products, while in fact the serialisation of pharmaceutical packs, commissioning and decommissioning is a great mean to prevent counterfeit medications from reaching an individual patient. For instance, in 2019, only a few months after the EU FMD compliance date, four packs of the cancer drug Avastin were detected and prevented from reaching the patient thanks to the specific end-to-end verification processes introduced with this directive.
A well protected healthcare supply chain brings benefits for ‘critical care in critical situations’. As GS1 standards are well used in the global healthcare supply chain, barcode scanning on the products reinforces supply chain integrity.
Today, around 70 economies are requiring or allowing the use of GS1 standards to implement healthcare requirements. For instance, Turkey introduced its Turkish Pharmaceutical Track and Trace System (İlaç Takip Sistemi, ITS) back in 2007. The ITS system covers all the steps of the supply chain, from production / import to dispense. GS1 standards are used to identify and mark medicines and stakeholders in this system. Another example is Argentina, when in 2011 the National Administration of Drugs, Foods and Medical Devices of Argentina (ANMAT) introduced its national drug traceability programme based on the use of the GS1 standards for traceability. These two traceability systems were among the first in the world to be fully and successfully implemented using GS1 standards.
Unfortunately, in the COVID-19 situation we also experienced shipping and manufacturing disruptions, that in many countries have led to a spike in falsified medicines. This heightens the need for collective efforts, not only for the present situation, but also to prepare supply chains for the future distribution of safe COVID-19 vaccines.
THE FRENCH CASE
The first Covid-19 pandemic wave emphasized the recurrent question of medicine shortages in Europe and more specifically in France. It concerned mainly a shortage of ICU drugs, including off-patent medicines such as curares, narcotics and analgesics. Such shortages may compromise patient care and pose a health security risk. Facing these major problems as from the end of March (and in April and May) 2020, the French Ministry of Health set up a crisis management team. Jean-Michel Descoutures, IHF representative in the GS1 Healthcare Leadership Team, was missioned in the Logistic pole with four other colleagues. They were to source these basic but needed drugs as the national market would be insufficient to treat the expected potential 14 000 ICU patients. The on-going pandemic also caused international competition for resources, and they had to mobilize all the possible sources of supply. On the international level, this implied involving embassies as well as the GS1 network. Some embassies did a tremendous effort, establishing the link between foreign companies and the Ministry of Health.
GS1 Healthcare brings together suppliers and hospital providers in order to develop and implement the GS1 standards, and is organized globally through member organizations (MOs) in 115 countries. This network with up-to-date knowledge of pharmaceutical companies and specially those producing safe and trustful drugs with an efficient supply chain service was highly appreciated and very useful during the crisis. This is how in France we quickly got connected to safe pharmaceutical companies to supply safe midazolam, propofol or curares. The French Health Agency for Medicines (ANSM) was helpful to approve the import of these medications. This international procurement was organized by the Logistic pole and then the national procurement and storage was done by Santé Publique France, the French national pharmaceutical company, in order to dispatch these ICU drugs in the several regions in France.
Fortunately, in France, not even at the apex of the crisis did the ICU-patients reach the expected numbers. Today in several hospital pharmacies, and especially in the region of Paris, you may find Chinese or Korean anesthetics or analgesics not being used for the current surgeries but as a safe supply in case needed in a second COVID-19 wave.