Healthcare logistics and temperature-sensitive healthcare products
15 December 2021 by Edina GÁLFI
Delivering refrigerated medicines to hospital : a logistical challenge
25 November 2021 by Edina GÁLFI
The delivery of refrigerated medicines to a university hospital involves a multitude of actors, which necessarily increases the risk of breaking the cold chain. The right temperature must be maintained at every stage: storage, transport and distribution. This can only be guaranteed by a combination of several prerequisites defined by the Guidelines on Good Distribution Practice of medicinal products for human use*: tracking of temperatures, compliance with transport conditions, type of packaging used, etc. However, nonconformities still occur and can lead to doubts as to the integrity of the cold chain in the distribution of temperature-sensitive health products.
In its joint statement with UNICEF issued on 19 November 2020,the World Health organisation (WHO) stated that “the “cold chain” is a system of storing and transporting temperature-sensitive products at recommended temperatures from the point of manufacture to the point of use. Effective management of the cold chain is key to maintaining the safety and potency of …[pharmaceuticals].” In addition, temperature-sensitive health products are divided into several categories in accordance with the pharmaceutical regulations and marketing authorisations.
The logistics circuit for temperature-sensitive medications
1/Delivery & responsibilities
Today, the regulatory framework covering the distribution of health products imposes a performance obligation: to prove that the conditions of conservation of medicines have been met during transit.
But who is responsible?
The logistics circuit for health products is complex and therefore so are the associated responsibilities. At each stage, a different actor has to guarantee that the conditions of conservation of the products transported are met: the industrial pharmacist must guarantee the right temperature is maintained until delivery at the university hospital. Once delivered to the general stores, the hospital’s logistics platform, responsibility lies with the hospital pharmacist, until the medicine is administered to the patient.
2/Delivery & safety
The safety criteria for delivering temperature-sensitive health products:
- Temperature indicator: in the form of a temperature sensor or a logging ticket;
- Compliance with regulations: temperature taken compliant with the ranges defined in the good practice guidelines;
- Visual identification of the nature of the refrigerated product: it must be mentioned on the packaging;
The risks associated with a non-compliant cold chain in the distribution of temperature-sensitive health products have implications for the medical treatment and therefore the heath of the patient: reduced efficacy of the active substance, risk of microbiological contamination, modification of the organoleptic and physical-chemical characteristics or the active substance and, finally, the formation of toxic derivatives.
Case study – the logistics of refrigerated medicines at Caen university hospital
The single-centre study conducted at Caen university hospital by the journal Revue Générale du Froid highlights two major issues impacting the integrity of the cold chain of temperature-sensitive health products:
- Equipment used: the use of brown cardboard boxes in standard, non-refrigerated trucks is a major issue for the security of the medicines administered to patients. Yet even when these boxes are transported in temperature-controlled trucks, the cold chain can still be broken (risk of boxes being unloaded and left standing in non-refrigerated unloading bays). Therefore, it is essential that deliveries be dealt with immediately, which requires strict organisation of the hospital’s operations.
- Handling of temperature excursions: legally speaking, a medicine cannot be subjected for more than 3 minutes to a temperature different to its maintenance temperature without there being a risk of deteriorating its properties and compromising its quality. The type of packaging used (non-insulated brown cardboard boxes) cannot guarantee a continuous cold chain.
3/Priority development areas for the delivery of temperature-sensitive health products in a university hospital
Secure packaging
Qualified insulated packaging with passive cooling to prevent temperature excursions during unloading and until the products are transferred to a refrigerated place. Marking “refrigerated product” or “+2°C/+8°C” on the insulated box allows for rapid visual identification and facilitates prioritisation in the management of the cold chain logistics for the products concerned.
Traceability
Inserting a temperature logging ticket is a way of detecting any excursions. Fluctuation curves are indicators that can provide valuable information on what needs to be improved at specific points in the distribution circuit. They also allow the requirements of protocols implemented by certain hospitals to be met.
The tracking is then optimum and can be done at every stage in the cold chain.
Recyclable packaging
The choice of certain types of insulated packaging is also guided by the sustainable development policies adopted by hospitals. EPP, a robust, lightweight, versatile material allows the adoption of reverse logistics processes and meets eco-responsibility concerns.
Optimising the logistics equipment used is therefore a way of guaranteeing the efficacy of the care provided, protecting a health system and preventing wastage of products and financial losses.
Our news in cold logistics
View the blog
