Preparation of sterile parenteral products is a critical component of health-system pharmacy practice. Over the last decade, many hospital/health-system pharmacy departments in the United States contracted with external organizations for the sterile preparation of parenteral medications.
Several important safety and quality implications must be considered when hospitals/health-systems decide to internalize or “insource” preparation of sterile parenteral products for use in the institution. These implications impact numerous stakeholders beyond the department of pharmacy, including physicians, nurses, and, most important, patients. Factors that must be considered when deciding whether to insource include:
- Patient safety
- Quality management specifically as it relates to facility cleaning and validation, staff training, and competency assessments
- Staffing needs/capabilities
- Information systems and other infrastructure
- Facilities/physical plant
- Education and training of pharmacy staff
- Organizational and pharmacy department policies and procedures for specific compounding practices
- Risk assessment
- Regulatory requirements and accreditation standards
- Inventory and supply chain issues
- Emergency preparedness implications
- Financial implications
These factors apply to all medications that have been outsourced by departments of pharmacy. However, additional focus should be directed to those medications that the evidence indicates are most frequently outsourced, including patient controlled analgesia and epidural solutions, oxytocin, intravenous admixtures/small volume solutions, anesthesia syringes, total parenteral nutrition, and cardioplegia solution. For the complete discussion, Download the Background on Insourcing I.V. Sterile Compounding Services document (PDF).