What is more precious and fragile than a human life? Emergency pharmaceutical logistics holds a considerable responsibility in its hands. Transporting vaccines or medicines in an emergency situation is not a trivial matter; its requirements are vital: the final link in the chain is human life.
It must therefore be of the highest quality and be extremely rigorous. The stakes are high, since they directly concern the patient’s health, and his or her chances of receiving a treatment adapted to his or her needs, at the right time and under the best conditions. Guaranteeing perfect traceability transparency and maintaining the quality and integrity of pharmaceutical products are imperative conditions.
In the midst of a health crisis, the pharmaceutical industry had to adapt to a sudden explosion in demand for drugs, vaccines and other pharmaceutical goods, resulting in massive stock shortages and consequent logistical challenges. This health crisis served to highlight the fundamental role of pharmaceutical logistics, and the striking importance of its responsibilities. Since its responsibilities are major, its demands are analogous. While the pharmaceutical industry is subject to a number of specific requirements and challenges, supply chain management is particularly complex.
From the pharmaceutical laboratory to the patient, via hospital pharmacies or pharmacies, medicines and vaccines must be transported in accordance with strict and standardized requirements.
To meet these imperatives, emergency transport and the pharmaceutical supply chain, governed by particularly strict legislation, must meet three fundamental criteria: quality, efficiency and safety.
BPDGs (Good Wholesale Distribution Practices) must « guarantee that the quality of medicines is maintained at all stages of the supply chain, from the manufacturer’s site to the pharmacy or the person authorized or entitled to dispense the medicine to the public » J.O 25/03/2014
To achieve this, quality management must check that medicines are acquired, stored, supplied or exported in compliance with GMP requirements. It will also check that medicines are delivered to the right recipients within the right timeframe. This quality management will be orchestrated by a person in charge of maintaining the QMS (Quality Management System): a person who is qualified, competent, experienced, trained in GMPD and available around the clock. The EAS international group has three
subsidiaries whose skills have been validated by specialized BPD firms. In addition to these quality certifications, the company is backed by a number of partnerships that enable first-rate distribution of pharmaceutical products, such as its AEO (Authorised Economic Operator) customs security status. With practical considerations in mind, EAS International has suitable and sufficient partners to ensure the proper storage and distribution of medicines, within a timeframe subject to urgency, as well as qualified equipment, such as validated software. Rigorous and demanding, EAS International ensures that its quality policy communication is fluid, up to date and understood by all supply chain personnel, including partners.
So, for pharmaceutical emergency transport to be prepotent, a rule, directing each of the choices and actions of the players in the chain, must orchestrate the transport: the 5 M rule. These correspond to the following points: Trained workforce, Environment (qualified storage infrastructures, secure access, mapping…), Methods (available, detailed, precise, validated, audited…), Drugs (identified, controlled…), Materials (identified, controlled…)
These 5 M’s ensure compliance with good distribution practices and the implementation of an efficient system for managing the transport of medicines and vaccines. The principal is responsible for subcontracted activities. From then on, he or she carefully selects the subcontractor, providing him or her with the information needed to preserve product integrity (ensuring compliance with the temperature chain, traceability, GMP compliance, audits, etc.), and draws up a contract with shared responsibilities. The subcontractor has suitable premises, equipment and/or vehicles. Its personnel are trained in GDP and may only subcontract to a third party with the agreement of the client. By respecting these requirements, and aware of the urgency of the service, the supply chain increases its efficiency… and consequently, its safety.
Efficiency must go hand in hand with safety, in response to a growing global problem: the fight against falsified medicines. According to the World Health Organization, 1 in 10 medicines is falsified or of inferior quality. « The falsification of medicines is a scourge whose consequences for public health can be serious, even dramatic. It is a global phenomenon, affecting all countries and sparing no therapeutic area. According to the WHO, this figure rises to one in four medicines if we consider only developing countries, according to the organization’s latest assessment, dated January 31, 2018.
According to IATA (the International Air Transport Association), this figure speaks for itself: 35,000 million dollars. This is the figure for total annual losses due to the problem of storing thermolabile medicines in air transport. EAS International, thanks to its air transport partnerships, is perfectly placed to reduce these risks.
Traceability of medicines and vaccines therefore requires complete transparency, both with regard to the product itself, and to its transport conditions (compliance with temperatures, packaging, etc.) in order to prevent risks and reduce losses.
In addition to the need to preserve patient’s lives, the financial stakes are considerable, since according to estimates by research firm Grand View Research, « the pharmaceutical logistics market will record overall growth of 3.5% every year until 2025 ».
Cost reduction in the pharmaceutical logistics sector, with a particular focus on risk management, is therefore a categorical imperative.Quality, efficacy and safety are the three decisive factors in maintaining a rigorous supply chain that complies with the legal conditions for the urgent transport of medicines and vaccines. It is therefore essential to ensure that the pharmaceutical industry’s good distribution practices are respected. Quality, the result of trust, is the key to customer satisfaction, the mother of risk anticipation, and the source of all organizational and practical thinking. An appropriate management system, based on compliance with regulatory standards and the requirements of pharmaceutical companies, is essential to ensure the factual reality of quality. The stakes are considerable, as they relate to multiple fields: human, health, organizational, legal, economic and social. The EAS international group, which has been an expert in emergency transport for 30 years, follows a utilitarian doctrine to ensure the best possible performance in the distribution of medicines and vaccines.
Propulsé par Spationaute.io