Background Compounded sterile drugs have to be prepared in appropriate conditions that ensure their safety in order to prevent medication error and avoid patient harm.
Purpose To analyse risks associated with preparation of intravitreal injections (aflibercept and ranibizumab) in our Pharmacy Department to classify them according to their risk level.
Material and methods A risk assessment was conducted to determinate the risk level that had to be applied in the preparation of aflibercept and ranibizumab intravitreal injections.
We used two documents as a base: ‘Guide to good manufacturing practice for medicinal products in hospital pharmacy services’, promoted by our national Ministry of Health, and a form elaborated by Group of Pharmaceutical Compounding of our national association of hospital pharmacists to calculate in an easy and quick way the final risk level.
Six items were analysed:
Route of administration.
Drug safety profile.
Number (quantity) of prepared units.
Sensitivity to microbiological contamination.
Distribution of the sterile preparation.
The assessment of each one resulted in a letter which ranged from the lowest (A) to the highest (D) risk. A combination of all letters allowed us to classify every drug preparation procedure at an appropriate level. If we obtained at least a ‘D’, it was considered a high-risk preparation; if there were a ‘C’ or at least three ‘B’ (and no ‘D’), it had a medium risk; and if less than three ‘B’ (and no ‘C’ and ‘D’) were present, it was classified as a low-risk preparation.
Results In the case of aflibercept and ranibizumab intravitreal injections we obtained more than one ‘C’ (and no ‘D’) when matrix risk was applied, and their preparation process was considered to have a medium risk level. It implies they had to be prepared in a laminar flow cabinet in a clean room and be stored in a refrigerator for 9 days.
Conclusion Matrix risk application to the compounding process of aflibercept and ranibizumab intravitreal injections in our Pharmacy Department has allowed us to classify them according to their appropriate risk level, and to check their preparation and conservation conditions.
No conflict of interest
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