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Question: Do you have any experience in dealing with temperature deviations from commercially available drugs (cold chain) from patients? Usually, we have appropriate judgments for clinical trial drugs, but commercial products are placed in the hands of patients without strict temperature monitoring, and the collected temperature data is difficult to ensure accuracy. Please advise on whether there are any additional issues that need to be considered in addition to product stability when dealing with this issue
Answer: Thinking direction: ⚫ Patients should stop using medication if they store it improperly and cause overheating after purchasing it. ⚫ If you contact the manufacturer due to the high cost of the medication, inquire if it is possible to continue using it. The manufacturer can assist in determining, but the final decision on whether to continue using it remains with the patient. ⚫ Whether the temperature preservation in the intermediate stages (transportation, pharmacy) strictly complies with the storage requirements also needs to be considered. Conclusion: ⚫ Acceptable temperature range; ⚫ Is the information on temperature deviation reliable? (Please inquire for detailed information) ⚫ Whether the temperature preservation in the intermediate stages (transportation, pharmacy) strictly complies with the storage requirements also needs to be considered. ⚫ The risk of providing positive suggestions (including adverse reactions or events after medication) requires a qualified person to conduct a comprehensive analysis and provide reasonable suggestions based on material safety. Reference "Good Manufacturing Practice for Pharmaceutical Products"