Global Risk Analysis applied to outsourcing Sterile Injectable Drugs

Julia Rousseau, Kaouther Zribi, Camille Cotteret, Salvatore Cisternino, Joël Schlatter
Service de pharmacie, hôpital Necker-Enfants Malades - 149 rue de Sèvres, 75015 Paris, France

Our hospital has undertaken an outsourcing of injectable preparations production in order to optimise costs and resources. Our production process would thus be subcontracted by another hospital in the group. However, outsourcing (OS) cannot be considered without a prior risks evaluation and has to take into consideration the specificity of paediatric preparations related to our bone marrow transplant activity. A Global Risk Analysis (GRA) was initiated to guide OS or not decision.

Materials and method
The GRA was conducted by a multidisciplinary working group (physicians, pharmacists, interns, nurse managers, pharmacy technicians). The GRA allow building cartography of the dangerous situations and prioritising them according to action priority index. Hazardous situations that have to be treated in priority are identified in scenarios rated according to their probability, severity and initial criticality (IC) (acceptable C1, acceptable under control C2, unacceptable C3). Scenarios where IC = C2 or C3 are dealt by implementing risk reduction actions. An effort scale can rate actions that have to be implemented. A residual criticality (RC) is attributed to each scenario after the actions implementation. Data analysis was performed using the Statcart® software (MAD Environment Company).

The working group met 20 times (50 hours) and identified 51 hazardous situations to be treated without delay, resulting in 92 accident scenarios including 43 with unacceptable criticalities. The GRA showed that the riskiest scenarios mostly concern management (42%) including organisation and human resources, but also hardware and IT equipment (17.5%) and logistical matters (12.4%). We wrote 25 risk reduction action sheets, among them 60% required a level 3 effort, thus reducing the risk rate IC = 3 (47%) to an acceptable risk rate with 85% with RC = 1 and 8.5% with RC = 2. However, 6 scenarios (6.5%) had a RC = 3. The working group concluded that it is impossible to outsource this part of the activity concerning the preparations with short stability, as well as the paediatric busulfan preparations which require dosage adjustment for conditioning regimen.

Discussion / Conclusion
The majority of risk reduction actions requires a great effort to set up and maintain a residual activity on the ordering site, which represents a significant cost. This GRA allowed us to identify the important risks related to OS injectable preparations production, particularly with paediatric and adult preparations. It will enable heads of departments to decide whether or not to implement OS.

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