Photoprotection versus patient identification safety : evaluation of overwraps for anticancer drug bags

The use of opaque bags is necessary to protect photosensitive anticancer drugs (AC), but their opacity complicates visual inspection and patient identification checks. Initial visual inspection results seemed to indicate the superiority of blue anti-UV O-Pack Blue bags (SLB Médical) over white anti-UV bags (JCE Biotechnology) in protecting Dacarbazine (DCZ), a highly photosensitive AC that forms a pink degradation product (DP) under light exposure. However, these new white bags offer an alternative, improving the readability of information (solvent, patient label) through the bag. The aim of this study was to confirm these visual inspection results by monitoring the evolution of DCZ and its spectrally distinct DP.
DCZ bags diluted to 0.625 mg/mL, prepared in triplicate, were stored in blue bags, white bags, or without an opaque overwrap (positive control, T+), and in complete darkness (T-). The bags underwent light stress in a thermostatically controlled chamber at 20°C at 7500 lux, with sampling at 0, 4, 20, 48, and 72 h. Samples were analyzed by flow injection analysis (FIA) UV-visible spectroscopy (190–800 nm), enabling spectral monitoring of DCZ and its DP. Transmittance tests from 325 to 700 nm were performed by spectrophotometry at 6 points on 6 bags of each reference, each analyzed 6 times, to assess protective efficacy and homogeneity.
In FIA, spectral analysis revealed bands of interest at 231, 321, and 521 nm. Analysis of the T+ bags showed rapid degradation of DCZ, evidenced by a sharp decrease in intensity at 232 and 321 nm, associated with the appearance of a spectral band at 521 nm. In both blue and white bags, the DCZ spectrum at 231, 321, and 521 nm remained similar up to 20 h of stress (150,000 lux-h) (intensity differences < 3%), indicating stability. DCZ degradation (decrease in intensity at 232 and 321 nm) was greater in blue bags after 48 and 72 h of stress, i.e., 360,000 lux-h and 540,000 lux-h. Transmittance tests showed good UV filtration for both references, with lower reflective capacity of blue bags in the visible range (residual transmission of blue bags > 10% at 425–450 nm).
This study shows that the photoprotective performance of white bags is superior to that of blue bags for chemical substances with highly conjugated structures such as DCZ, and remains acceptable, in contrast to the results obtained by visual inspection and to the common belief that UV opacity is the key criterion for selecting a photoprotection device. These findings should be interpreted in light of the challenges of securing the medication circuit : the ability to read the label through the overwrap is an asset for patient identification safety. An HPLC-UV study will allow quantification of the degradation of diluted, photo-stressed DCZ stored in white and blue opaque bags.

Keywords : patient identification, drug stability, photodegradation, spectroscopy

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