A mixed-methods study investigating the potential and challenges of generic substitution of controlled substances in community pharmacies

Background Using generics became an established practice. Studies about dispensing practices of generic controlled substances are scarce. Objective We investigated dispensing practices of generic controlled substances compared to non-controlled substances, challenges community pharmacists face when substituting them, and how they can be better supported. Methods A mixed-methods approach was employed. We descriptively analyzed prescribing and dispensing rates of originals and generics of controlled and non-controlled substances. Ten community pharmacists were interviewed to investigate challenges and support options. Results Seven hundred eight prescriptions were included in the data analysis. Physicians prescribed 54 % (167/307) of originals for controlled substances and 50 % (202/401) of originals for non-controlled substances ( p > 0.05). A total of 37 % (62/167) of prescriptions for original controlled substances were substituted with generics in community pharmacies in contrast to 74 % (149/202) of prescriptions for original non-controlled substances ( p < 0.001). Challenges mentioned by the interviewees included gaining trust in the context of generic controlled substance use, meeting patients' needs, and legal regulations. They named support measures, such as patient education by physicians, and reduction of the administrative workload. Conclusion The analysis revealed a significantly lower substitution rate for controlled substances compared to non-controlled substances in pharmacies. Yet, physicians showed similar prescribing rates of originals and generics. The findings support the need to strengthen the collaboration between healthcare providers, and to improve education as well as awareness to ensure adequate patient care when substituting generic controlled substances.