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Assesing cold chain compliance for biotherapy drugs in a university hospital’s medical departments

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European Statement

Patient Safety and Quality Assurance

Author(s)

AMINE BAYEN, OUMAIMA KHARKHACH, HICHAM EL HORR, LHOUSSAIN ZARAYBY, SANAE DERFOUFI

Why was it done?

It has been observed that within the gastroenterology, neurology, internal medicine, rheumatology, and dermatology departments, there exist inconsistencies and disparities. These include extended transportation times averaging 8 minutes, a lack of isothermal bags for transportation, and refrigerators not connected to the main hospital generator.
Strict adherence to storage guidelines is crucial, as any breach in the cold chain could compromise the drug’s therapeutic effectiveness, increase the risk of adverse effects, and lead to significant financial losses for healthcare institutions.

What was done?

Ensuring optimal storage and transportation conditions for biotherapy drugs in various medical departments within a university hospital by assessing and improving cold chain compliance.

How was it done?

Implemented corrective actions and recommendations have been primarily directed towards minimizing transportation duration and procuring thermal bags for all departments handling biotherapy products. These initiatives encompass enhancing staff awareness in the cold chain process through sensitization campaigns and regularly evaluating refrigerator temperatures. Moreover, a strategic plan is underway to establish their connectivity to the generator system in the near term.

What has been achieved?

A notable reduction in the transportation time of biotherapeutic drugs has been achieved, decreasing the average duration from 8 minutes to 6 minutes. Additionally, the widespread adoption of thermal bags across audited departments has substantially bolstered the stability of biotherapeutic drugs, mitigating temperature fluctuations and enhancing patient safety. Moreover, our efforts in sensitising medical and pharmaceutical staff within these departments have yielded a significant increase in awareness and adherence to stringent cold chain protocols.

What next?

The inconsistencies and disparities identified during the assessment of the biotherapy drug cold chain within our hospital suggest a potential lack of adherence to procedural standards. This situation poses a considerable risk to patient safety, warranting further investigation and action.
Our focus will extend beyond the cold chain assessment to evaluate other pharmaceutical procedures. Specifically, we will investigate the adherence to autoclave sterility cycles for medical devices and the robustness of the preparation process for oncology medicines.

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