Messages from the PDA Conference on Cold Chain Management
By Heike Kofler, PhD
The responsibility for protecting a temperature-sensitive drug product should be shared by all supply chain stakeholders to ensure patient safety. Any deviation from the defined temperature range that occurs during manufacturing, distribution and storage might impact patient health and recovery. Temperature-controlled supply chain integrity not only refers to cold-chain-maintained drug product distribution, but also to medicine that should be kept at ambient temperatures. The aim is clearly to maintain product quality, safety and efficacy, which can be achieved by minimizing risks such as product degradation, product adulteration, counterfeiting and theft.
Temperature-controlled supply chain integrity and security were among the topics discussed at the Parenteral Drug Association conference on Cold Chain Management in Berlin in October 2012. Challenges include the complexity of global distribution, environmental conditions, geopolitical boundaries, local lack of a reliable infrastructure and different regulations worldwide. Temperature monitoring is mandatory and supported by various technologies such as USB (universal serial bus) data loggers, radio-frequency identification (RFID) and even real-time monitoring via GPRS (general packet radio service) tools. Data analysis, storage and protection, as well as the organizational challenges in cross-supply-chain coordination are critical since all sub-contractors need to use the same technologies.
Awareness, visibility and transparency are important targets for improvement. This is especially difficult for the last step of the so called “Last Mile”: the delivery of the drug product from pharmacies to patients. A new Good Distribution Practices guideline for Europe is currently under review and will be implemented in 2013. Also, the Unites State Pharmacopeia (USP) is developing a new version of the standard regarding pharmaceutical supply chain integrity. The new standard will include education of inspectors and investment in new technologies or upgrading existing equipment by companies involved in the supply chain of temperature-controlled drug products. Economically these expenditures may find some compensation in the reduction of wasted drug products for which the temperature profile is unknown if returned to the pharmaceutical industry or wholesaler. A complete temperature log file could save money, but what is far more important is that the security and integrity of a temperature-controlled supply chain may enhance the safety and efficacy of the drug product that ultimately reaches the patient.
Reference and acknowledgements to Erik J. van Asselt, PhD, PCCIIG EU Branch Leader and Rafik H. Bishara, PhD, PCCIG, PCCIG USA Branch Leader as organizers of the PDA Conference Cold Chain Management Berlin 2012