Safety-I Versus Safety-II: A Mixed-Methods Study Revealing the Imbalance of Approaches in Primary Care Medication Safety.

Objectives: Our objective was to develop an in-depth understanding of the barriers and facilitators for medication safety in primary care by synthesizing findings from a multiyear, multisite study of care teams, pharmacists, and patients, using Safety-I and Safety-II lenses.

Methods: We used mixed methods, including a systematic literature review and interviews on medication use in ambulatory primary care. We synthesized the findings using Safety-I and Safety-II lenses to identify safety challenges and strategies.

Results: Published challenges and strategies were mostly framed through a Safety-I lens: establishing ever-expanding best practice algorithms and using them to decrease variability. In contrast, our analysis of patient and professional perspectives revealed that medication safety in ambulatory settings is undermined by the complexities of distributed work systems including poorly implemented safety checks; limited support for self-management; weak safety infrastructure; conflicting interests; and external forces beyond the control of patients and primary care professionals. We also identified actions by clinicians and pharmacists to improve medication safety that fall outside traditional compliance-focused Safety-I strategies. These actions were often initiated to overcome barriers in distributed work systems, highlighting the importance of Safety-II strategies in primary care.

Conclusions: This study revealed a fundamental limitation in applying Safety-I principles to primary care medication safety, particularly the assumption that all system defects can be feasibly fixed. Given the complex realities of primary care, a complementary Safety-II perspective is essential, as it recognizes the agency of professionals and patients in managing risks within distributed work systems affected by uncontrollable external forces.