Desk review of the pharmaceutical quality management system for the integrated community. Case study: Management of childhood illnesses in Guinea-Conakry

Abstract

The C-IMCI in Guinea is a new program and it was a good case as scope of application in regards to the courses pursued, and an opportunity to contribute to raise awareness and initiation of a formal quality management system in the community pharmaceutical management. The general objective of this study aimed at conducting a documentation third party audit of the existing legal framework, policies, guidelines and tools of the C-IMCI program and revising them in order to comply with the full recommendations of the WHO and MHPH requirements for pharmaceutical management system. The research was observational study based on documentary analysis and interviews and was conducted in the 5 prefectures of the Republic of Guinea where C-IMCI had been implemented at the time of the study – Boffa, Coyah, Dubréka, Forécariah and Fria. The CHWs interview consisted of two sections: 1) Basic demographic information and 2) Utilization of pharmaceutical management tools. Interviews were carried out at health centers (HCs). Data collection forms were developed in French including semi-structured questionnaires with members of the MoH/IMNCI unit and CHWs and in-depth interviews with the same persons on the possible options for improving the pharmaceutical management system. Our study focused on two parameters of the 5M method, namely: Manpower and Methods. Interviewee names were not collected. Data collection was conducted using five main methods namely 1) desktop audit of policies and guidelines to be sure they contained relevant pharmaceutical management issues and were in line with current World Health Organization recommendations and other international norms and standards, 2) semi-structured interviews with members of the MHPH/IMNCI unit and CHWs based on questionnaire, 3) in-depth interviews with the same on the possible options for improving the pharmaceutical management system, 4) review of the utilization of the pharmaceutical management tools by CHWs, and 5) quality audit checklist. The collected C-IMNCI package documents were audited against the WHO recommendations and the MHPH requirements for pharmaceutical management. The evidence 6 collected have been examined and documented for each identified gaps. Evidences collected through interviews have been, whenever possible, confirmed by more objective means. Investigational clues that point to possible gaps have been thoroughly investigated. Overall, we found that male and female CHWs are not equally represented. It appeared that all the CHWs have been elected by and lived in their communities, and physically fit to travel for business but the criterion on education level was sometimes not respected. They were all trained to carry out their duty. But no supervisors receive training on how to supervise CHWs. We found that 96% of stock card were correctly filled and 92% were up to date while 66.3% of the monthly report were correctly filled but the submission rate of the monthly report was low (57.5%). After reviewing the 12 documents of the C-IMNCI package, we proposed that 3 remained unmodified, 6 should be amended and 3 should be dropped out. Beside this, 3 others documents should be fully drafted. The technical specifications for the medicines and RDT have not been sufficiently clearly defined in the Implementation Guide to ensure the procurements are for the appropriate products. Technical specifications for medicines should reflect consideration of program details and intended recipients and the unique context in which most CHWs perform their services, and medicines need to be in a formulation that is both age-appropriate for recipients and supply chain-friendly. We found that there is no QMS in place although the C-IMCI Program has already some of the documents of a QMS: elements of 2nd and 3rd thirds level of a quality management system.