Going the Extra Mile

By Jean Bédard, Alternatives Technologie Pharma Inc.

Wouldn’t it be nice if the pharmaceutical supply chain could comply with cold chain regulations from manufacture to end-user?

The Cold chain concept refers to all resources that are required to maintain temperature-sensitive pharmaceutical products within temperature limits as specified by manufacturers, from production to final distribution, down to the end-user or patient (last-mile distribution). Compliance requirements for storage and distribution of temperature-sensitive products have been edited by many organizations, including World Health Organization (QAS304.068), Health Canada (IDGPSA, Guide-0069) and United-States Pharmacopoeia (USP <1079>).

While a great emphasis is put on the control and monitoring for storage and transport conditions from the manufacturers to the wholesalers, a lot of work has still to be done for the very last-mile distribution steps. In 2008, between 17 and 37 percent of healthcare suppliers were found to expose vaccines to inappropriate storage conditions, especially in temperature, with storage equipment being too cold rather than too warm.

However many retailers, healthcare professionals and end-users still are unaware of the new management and compliance challenges for the last-mile distribution of pharmaceuticals. Today, guidelines and standards tend to contain the whole supply chain, including the very last-mile components  like pharmacists and healthcare professionals. Boards of Pharmacy started to install cold chain storage and distribution guidelines. For shipments from pharmacies to patients or end-users, procedures and documentation for receiving and storage of products are required, with all documents and records being adequately maintained. Further, temperature standards should be installed and storage temperatures should be monitored and controlled. Actions should be taken when temperature deviations occur.

To help pharmacies and other institutions in maintaining good cold chain control, Alternatives Technologie has developed simple and effective solutions:

• Procedures and Documentation: A kit of preformatted procedures and documentation is available, and can be rapidly adapted to pharmacies, in regard to the receiving, storage of drugs, storage equipment and shipping/delivering processes. Self-auditing templates and training materials are also provided.
• Storage Equipment: The pharmacist has to possess a refrigerated equipment to store products between 2°C and 8°C, whether it is a domestic refrigerator or a laboratory refrigerator (avoid 'bar' type refrigerators). In order to know the performance of the equipment and to comply with regulations, we have developed a mapping tool kit (protocol, data loggers and procedures) to perform temperature distribution studies of refrigerators.
• Temperature Control and Monitoring: To meet financial challenges and make it affordable, we've introduced a solutions that enables to monitor the storage temperature (equipment, shelves) without investing a lot of money on heavy monitoring system and having to manage hardware, software and database. A vendor-hosted Web Wireless Monitoring system monitors continuously the temperature inside the pharmacy's storage areas and equipment. The pharmacists simply have to install the wireless temperature sensors and to plug the reader module. Then, individual and secured monitoring accounts can be set up through a common web portal. Current and historical temperature data are readily accessible under secure session from a central database. Furthermore, the pharmacist can configure his account and temperature alarms. To help pharmacists, we also have created a vendor-hosted data logger management system based on the same model.
• Delivering and Shipping Container: A kit of pre-qualified reusable portative containers is offered to pharmacies, with different sizes and different temperature ranges being available. Such containers are equipped with conditioning material kits in order to maintain the products during delivery and distribution to the end-users. Additionally, individual conditioned bags to be provided with temperature-sensitive products to end-users are also available.

With these new products and services adapted to the last miles actors, there is no reason not to have a complete and secure supply chain that can protect the integrity of medicines and preserve all their therapeutic properties from raw material to the end-users. It's time for these last miles actors to jump in the cold chain train to make sure that their patients get the right and secure medicine to help them stay healthy.

Jean Bédard is Chief Executive Officer for Alternatives Technologie Pharma Inc. and holds a MBA in Bio-industry Management. Since 2003, he has led the company and its impressive team of cold chain and track & trace management experts, and has managed more than 100 cold chain compliance programs in the Life Sciences and Healthcare sectors.