title: First regulatory inspections measuring adherence to Good Pharmacy Practices in the public sector in Uganda: a cross-sectional comparison of performance between supervised and unsupervised facilities.
abstract: BACKGROUND
  Since its inception, the Uganda National Drug Authority (NDA) has regularly inspected private sector pharmacies to monitor adherence to Good Pharmacy Practices (GPP). This study reports findings from the first public facility inspections following an intervention (SPARS: Supervision, Performance Assessment, and Recognition Strategy) to build GPP and medicines management capacity in the public sector.
  
  
  METHODS
  The study includes 455 public facilities: 417 facilities were inspected after at least four SPARS visits by trained managerial district staff (SPARS group), 38 before any exposure to SPARS. NDA inspectors measured 10 critical, 20 major, and 37 minor GPP indicators in every facility and only accredited facilities that passed all 10 critical and failed no more than 7 major indicators. Lack of compliance for a given indicator was defined as less than 75 % facilities passing that indicator. We assessed factors associated with certification using logistic regression analysis and compared number of failed indicators between the SPARS and comparative groups using two sample t-tests with equal or unequal variance.
  
  
  RESULTS
  57.4 % of inspected facilities obtained GPP certification: 57.1 % in the SPARS and 60.5 % in the comparative group (Adj. OR = 0.91, 95 % CI 0.45-1.85, p = 0.802). Overall, facilities failed an average of 10 indicators. SPARS facilities performed better than comparative facilities (9 (SD 6.1) vs. 13 (SD 7.7) failed indicators respectively; p = 0.017), and SPARS supported facilities scored better on indicators covered by SPARS. For all indicators but one minor, performance in the SPARS group was equal to or significantly better than in unsupervised facilities. Within the SPARS (intervention) group, certified facilities had < 75 % compliance on 7 indicators (all minor), and uncertified facilities on 19 (4 critical, 2 major, and 13 minor) indicators.
  
  
  CONCLUSIONS
  Half of the Ugandan population obtains medicines from the public sector. Yet, we found only 3/5 of inspected public health facilities meet GPP standards. SPARS facilities tended to perform better than unsupervised facilities, substantiating the value of supporting supervision interventions in GPP areas that need strengthening. None compliant indicators can be improved through practices and behavioral changes; some require infrastructure investments. We conclude that regular NDA inspections of public sector pharmacies in conjunction with interventions to improve GPP adherence can revolutionize patient care in Uganda.
authors.affiliation: Management Sciences for Health, Plot 15, Princess Anne Drive, Bugolobi, P.O. Box 71419, Kampala, Uganda.
authors.forename: Birna
authors.initials: B
authors.lastname: Trap
authors.affiliation: National Drug Authority, Plot 46 - 48 Lumumba Avenue, Kampala, Uganda.
authors.forename: Kate
authors.initials: K
authors.lastname: Kikule
authors.affiliation: Harvard Pilgrim Health Care Institute, 133 Brookline Avenue, 6th Floor, Boston, MA 02215 USA.
authors.forename: Catherine
authors.initials: C
authors.lastname: Vialle-Valentin
authors.affiliation: Management Sciences for Health, Plot 15, Princess Anne Drive, Bugolobi, P.O. Box 71419, Kampala, Uganda.
authors.forename: Richard
authors.initials: R
authors.lastname: Musoke
authors.affiliation: USAID/Securing Ugandans' Right to Essential Medicines Program (SURE), Plot 15, Princess Anne Drive, Bugolobi, P.O. Box 71419, Kampala, Uganda.
authors.forename: Grace Otto
authors.initials: GO
authors.lastname: Lajul
authors.affiliation: USAID/Uganda Health Supply Chain Program, Plot 15, Princess Anne Drive, Bugolobi, P.O. Box 71419 Kampala, Uganda.
authors.forename: Kim
authors.initials: K
authors.lastname: Hoppenworth
authors.affiliation: USAID/Securing Ugandans' Right to Essential Medicines Program (SURE), Plot 15, Princess Anne Drive, Bugolobi, P.O. Box 71419, Kampala, Uganda.
authors.forename: Dorthe
authors.initials: D
authors.lastname: Konradsen
keywords: Medicines management; Pharmacy certification; Pharmacy indicators; Pharmacy inspection; Pharmacy practices; Public sector; Regulatory authority; Supervision; Uganda