pharmacy certification

The National Drug Authority (NDA) inspects and certifies private and public sector pharmacies in Uganda using an indicator-based inspection tool that measures adherence to good pharmacy practices (GPP). 67 measures identify the situation in the domains of premises, dispensing quality, stores management, and operating requirements. Although the GPP measures are well-recognized and used internationally, little is known about their validity and reliability. The study aimed to assess validity, which measures agreement of GPP measures between a gold standard inspector and NDA inspector and inter-rater reliability (IRR), which measures agreement among NDA inspectors, of GPP measures. We assessed validity and IRR by four teams of inspectors in eight government health facilities that represent three levels of care. Each team inspected two facilities, resulting in 24 total inspections. Our findings question the validity and reliability of many GPP inspection measures, particularly critical measures that greatly impact certification decision. This study demonstrates the need for assessments of, and interventions to improve, validity and reproducibility of GPP measures and inspections.

Half of the Ugandan population obtains medicines from the public sector. Yet, we found only 3/5 of 455 inspected public health facilities meet Good Pharmacy Practice (GPP) standards. Facilities using SPARS (the Supervision, Performance Assessment, and Recognition Strategy) tended to perform better than unsupervised facilities, substantiating the value of supporting supervision interventions in GPP areas that need strengthening. Non-compliant indicators can be improved through practices and behavioral changes; some require infrastructure investments. We conclude that regular National Drug Authority inspections of public sector pharmacies in conjunction with interventions to improve GPP adherence can revolutionize patient care in Uganda.

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