Fewer stories and more SOP’s! Why should I care about pharmacy compounding Standard Operating Procedures?
Dr. Elaine Strauss, PharmD, MS / WB | Clinical / Jan 3, 2019
Stop telling stories! Are your trainers passing down pharmacy training information as if it is pharmacy folklore? Or, are they relying on a training manual that is grounded in detailed standard operating procedures?
Have you taken a look at your SOPs lately? Does your pharmacy/organization even have an organized set of SOPs covering the entire scope of pharmacy compounding? Look again! Many organizations rarely have this covered and the ones who do likely have a dedicated pharmacy quality team. With most hospitals around the country being small to medium-sized, managing the day to day safety and regulatory issues pose enough of a challenge that leadership often puts SOPs on the back burner. It’s unfortunately too easy to do.
Most state board of pharmacy regulations discuss the requirement of accurate, detailed, and updated SOPs. Accrediting organizations such as The Joint Commission have also increased their focus on medication compounding. Surveyors are now spending more time in the compounding area, and are trained to focus on areas such as leadership, people, and policies.
If you’re not quite sure how to start developing your SOPs, here are a few tips on how to begin your journey. First, who is designated to review and revise your SOPs? Get front-line staff involved in the review process – they’re likely making small procedural improvements overtime that may not yet be reflected in print within an SOP. Staff can get too creative with workarounds. Often, these procedural changes make sense, and should be adopted across the board.
Your SOPs should all consistently include the following items: numbering system, purpose/introduction, scope/responsibility, definitions, materials/equipment, procedure statement, related record keeping, related SOPs, effective date, and revision history. Also, consider whether your SOP’s cover all the entire scope of your compounding operation:
- administrative
- safety
- equipment/supplies
- personnel requirements
- master formulary
- quality assurance
- hazardous drugs
- training program
- facility cleaning
- compounding process
- inventory control
- reference documents
Ensuring consistency and eliminating variability across staff members and compounding sites is the ultimate goal of your SOP program, which contributes to a high-quality compounded product and patient safety.
For help getting started with building or revising your pharmacy SOP program, get in touch with the team at WorkingBuildings for support with Pharmacy SOP development and other pharmacy compounding needs.