Building a Culture of Safety for Compounding

Good compounding practices are founded on quality management, which includes an organization-wide commitment to following safe compounding practices. The following figure summarizes how that commitment is demonstrated.

Did you know, compounding has a high risk of causing very serious harm if not done correctly?

• Serious consequences, including death, have resulted from incorrectly compounded products, both sterile¹  and non-sterile?^2,3
• Many of the problems encountered in compounding cannot be reduced or solved by a set of procedures: there are many unknowns and unrelated factors.
• The more complex and complicated the processes become, the higher the risk of error.
• Compounded products, their processes, and the environment where compounding occurs are not subject to the same level of scrutiny as commercially available products.

The safety of the patient and those who handle the compounded preparations takes priority over other performance expectations.

• Pharmacists and pharmacy technicians routinely ask the question, "Should we make this compound?"
  • A risk assessment for "innovative" products is conducted.
  • Staff are comfortable saying "no" when the risk of the product exceeds the benefit.
• All persons (e.g., pharmacy technicians, physicians, nurses, pharmacists) who compound medications are held accountable to the same set of standards for compounding practices.

A culture of safety and continuous improvement is embedded throughout compounding practices

• Staff are keenly aware of where and how risk enters the system
  • They anticipate possible unintended consequences of that risk.
  • You know how that happens.
• Pharmacy staff know what's working well, or where the compounding system is weak or is failing.
  • Corrective action is taken to address any deficiencies in the system.
  • Inspections are conducted to assess and ensure compliance with policies and procedures and expected practices.
• Pharmacy leadership encourages and supports continuous assessment and improvement in compounding practices.
  • Staff are encouraged and supported to report all errors, near-misses, complaints, and recalls.
  • The director or manager reviews the reports on a frequent, regular basis.
    • I am aware of the results of the reports, corrective or preventive action that needs to be taken.
• All staff "stop the line" and report all concerns about an activity that could result in harm to a patient or anyone else, or any other concerns.
• A knowledgeable supervisor or manager can be reached 24/7.

Collaboration across all levels of responsibility in the organization and among all stakeholders.

• The roles and responsibilities of every member of the team involved in compounding are defined and understood by other team members.
• The organization considered safe compounding activities to be a shared interdisciplinary responsibility that does not rest only with pharmacy.
  • Knowledge and skill is shared among all  healthcare professionals in the organization who aseptically prepare medications.
• The people who have the knowledge of how to develop solutions are involved in creating those solutions.
• The management of the compounding service rely on the knowledge and skills of an interdisciplinary team that includes pharmacy technicians; pharmacists; other healthcare professionals who prepare, prescribe or administer compounded preparations and monitor patients for their response to the drug; engineers; facilities management staff; housekeeping staff; infection control and prevention staff, etc.

Investment in an infrastructure that adequately supports the people and the processes they perform related to compounding.

• The infrastructure is appropriate for the work undertaken, and is supported by a suitable work environment, right equipment, up-to-date and accurate information, supplies, and other resources.
  • I am aware of which resources are inadequate, and have executed a plan to address the situation.
  • I know the organization's limits and capacity to provide safe compounding services.
• Healthcare professionals who compound have the knowledge, skills, and attitude to safely fulfill their responsibilities.
  • They have opportunities to continually develop their competencies with regards to compounding, to apply them, and to share their learning with others.
• Managers and supervisors have the knowledge, skills, and attitude to safely fulfill their responsibilities.
  • They have opportunities to continually develop their competencies with regards to compounding, to apply them, and to share their learning with others.
• The pharmacy department has a program to regularly validate the quality of its compounding procedures.
• The compounding service participates in practice research to create new knowledge about how to improve processes or compounded preparations.
  • The service incorporates best (or better) practices that are based on evidence.
  • Experiences and knowledge is shared with other organizations to increase the collective knowledge related to compounding practices.

Literature Cited

1.  Death Associated with an IV Compounding Error and Management of Care in a Naturopathic Centre. ISMP Canada Safety Bulletin 2018; 18(1). Available from:  https://www.ismp-canada.org/download/safetyBulletins/2018/ISMPCSB2018-01-Selenium.pdf

2. Death Due to Pharmacy Compounding Error Reinforces Need for Safety Focus. ISMP Canada Safety Bulletin, 2017; 17(5). Available from: https://www.ismp-canada.org/download/safetyBulletins/2017/ISMPCSB2017-05-Tryptophan.pdf.

3. Oral Clonidine Suspension:  1000-Fold Compounding Errors Cause Harm to Children. ISMP Canada Safety Bulletin, 2011; 11(1). Available from: https://www.ismp-canada.org/download/safetyBulletins/ISMPCSB2011-01-ClonidineSusp.pdf.