Intro -- Foreword -- Preface -- Acknowledgements -- Introduction -- Aims of the Standards -- Development of the Standards -- How to use this Standards document -- Refugee and migrant health: Global Competency Standards for health workers -- Domain 1: people-centredness -- Explanatory notes -- Competency standard 1: provides people-centred health care to refugees and migrants -- Competency standard 4: supports refugees and migrants to understand information about their health care -- Competency standard 5: engages in collaborative practice to promote the health of refugees and migrants -- Competency standard 9: contributes to a culture of self-care and mutual support when providing health care in the context of migration and displacement -- References -- Figure 1: Prequalification status of the collected ARV products -- Figure 2: Overall compliance of the evaluated samples with WHOPARs -- Figure 3: Overall manufacturer compliance of collected samples with WHOPARs -- Figure 4: Overall compliance by country of the collected samples with WHOPARs -- Figure 5: Overall product compliance of the collected samples with WHOPARs -- Figure 6: Compliance of the evaluated SmPC samples with the WHOPAR SmPCs -- Figure 7: Compliance of the evaluated SmPC sections in the provided PI with the WHOPAR SmPC sections -- Figure 8: Serious violations regarding the dosage identified in the collected SmPCs -- Figure 9: Serious violations identified in the collected SmPC sections concerning the therapeutic indications -- Figure 10: Distribution of different identified format structures of the evaluated samples -- Figure 11: Included prescribing information in the evaluated product packages, in relation to the different format structures -- Figure 12: Distribution of the different identified format structures across the manufacturers.

Figure 13: Distribution of the different identified product information structures in the surveyed countries -- Figure 14: Compliance of the evaluated PILs with WHOPAR PILs -- Figure 15: Compliance of evaluated PIL sections in collected samples with the respective WHOPAR PIL sections -- Figure 16: Overall manufacturer compliance of collected PILs with WHOPAR PILs -- Figure 17: Overall country compliance of the evaluated 28 PILs with WHOPAR PILs -- Figure 18: Product compliance of the evaluated PIL with the WHOPAR PIL -- Figure 19: BALD score distribution of the evaluated PILs -- Figure 21: Evaluation of the document structure of the 28 evaluated PILs -- Figure 22: Frequency of use of WHOPARs and PQTm-website -- Figure 23: Evaluation of a potential relationship between Internet access and awareness and usage of WHOPARs and the PQTm-website -- Figure 24: Sources of ART information most often used by interviewees -- Figure 25: Respondents' evaluation of medical information in PI -- Figure 26: Interviewees' evaluation of the medical information in the PIL -- Figure 27: Identified shortcomings in PIL format and readability -- Figure 28: Interviewees' responses when asked about information supplied with ART products -- Figure 29: Compliance with storage conditions, as reported by dispensing staff -- Figure 30: Frequency of complaints about dispersible tablets, as stated by interviewees -- Table 1: Structure of a WHOPAR as described on the WHO PQTm-website -- Table 2::Modified Baker Able Leaflet Design (BALD) Assessment Tool -- Table 3: Collected ARV drugs for this survey in the five selected countries -- Table 4: Manufacturers of the sampled ARV products -- Table 5: Innovator product list and availability of public access to PI of the products -- Table 6: Mean BALD score of the PILs by surveyed manufacturer.

Table 7: Mean BALD score of the PILs in the surveyed countries -- Table 8: Mean EQIP scores of the evaluated PILs in the surveyed countries -- Table 9: Mean EQIP scores of the evaluated PILs for the surveyed manufacturers -- 1 Acknowledgements -- 2 Abbreviations -- 3 Executive summary -- 4 Introduction -- 5 Rationale for the survey -- 6 Scope of the survey -- 6.1 Objectives of the survey -- 7 Methodology -- 7.1 Main activities -- 7.2 Sample collection -- 7.3 Review of product information -- 7.3.1 Review of product information for the healthcare provider -- 7.3.2 Review of product information for the patient -- 7.4 Evaluation of the format of the product information -- 7.5 Evaluation of the readability, layout and design of patient information leaflets -- 7.5.1 Evaluation tool: EQIP Score -- 7.5.2 Baker Able Leaflet Design (BALD) criteria -- 7.6 Evaluation questionnaire on healthcare providers' awareness, perceptions of quality and use of WHOPARs -- 7.7 Evaluation questionnaire on the acceptance of dispersible tablets for paediatrics -- 8 Results -- 8.1 Overview of the samples collected -- 8.2 Compliance of product information with WHOPAR or Innovator PI -- 8.2.1 Sample eligibility -- 8.2.2 Overall compliance with published WHOPAR information -- 8.2.4 Compliance of medical information in provided SmPCs with WHOPAR SmPCs -- 8.2.5 Collected samples' format compliance with WHOPAR format -- 8.2.6 Compliance of medical information in provided PIL with WHOPAR PIL -- 8.3 Quality, readability, layout and design of the PILs -- 8.3.1 Sample eligibility -- 8.3.2 Language -- 8.3.3 Readability of the PILs -- 8.3.4 Baker Able Leaflet Design (BALD) assessment of the PILs -- 8.3.5 Ensuring Quality Information for Patients (EQIP) evaluation of PILs.

8.4 Evaluation of the awareness, usage and perceived value of WHO PQTm-website and WHOPARs among healthcare providers in the surveyed African countries -- 8.4.1 Experiences of healthcare professionals in the surveyed countries in accessing PQTm-website product information (WHOPARs) and ARV product information -- 8.4.2 Awareness and use of WHOPARs -- 8.4.3 Review by healthcare providers of the quality of product information -- 8.4.4 Review by healthcare providers of the quality of PILs -- 8.4.5 Dispensing staff -- 8.5 Evaluation of acceptance levels of selected dispersible paediatric ARV products in the surveyed African countries -- 8.5.1 Healthcare providers' experience relating to acceptance levels of selected dispersible paediatric tablets in the surveyed countries -- 8.5.2 Complaints about taste, flavour, sweetness or bitterness -- 9 Discussion -- 9.1 Objectives, achievements and limitations of the study -- 9.1.1 Objectives -- 9.1.2 Strengths and limitations of methodology -- 9.2 Overall findings -- 9.3 Objective 1: Evaluation of the compliance of sampled product information with WHO norms, standards and approved PQT information -- 9.3.1 Overall compliance of collected ARV products with WHOPARs -- 9.3.2 Overall manufacturer compliance with WHOPAR or innovator information -- 9.3.3 Overall country compliance with WHOPARs -- 9.3.4 Overall product compliance with WHOPARs -- 9.3.5 Compliance of SmPC medical content with WHOPAR SmPC -- 9.3.6 Compliance of PIL medical content with WHOPAR PIL -- 9.3.7 Overall format compliance with WHOPARs and layout and design of the evaluated ARV product information -- 9.4 Objective 2: Evaluation of the readability, format, layout and design of the collected PILs -- 9.4.1 Manufacturer practice of providing a PIL -- 9.4.2 Language -- 9.4.3 Readability of the evaluated PILs -- 9.4.4 Format of the evaluated PILs.

9.4.5 BALD criteria of the evaluated PILs -- 9.4.6 EQIP score of the evaluated PILs -- 9.5 Objective 3: Evaluation of the value of PQTm-website product information (WHOPARs) and ARV product information for healthcare providers in the surveyed African countries -- 9.5.1 Review by healthcare providers of the SmPCs of market ARV products -- 9.5.2 Review by healthcare providers of the PIL of market ARV products -- 9.6 Objective 3: Evaluation of the acceptance of selected ARV paediatric dispersible tablets in the surveyed African countries -- 9.7 Comments from surveyed countries -- 9.8 Comments from manufacturers -- 9.9 Comments from WHO -- 10 Proposals for WHO-PQTm on future improvements -- 10.1 Improvement of WHOPAR compliance -- 10.1.1 Consultation with manufacturers -- 10.1.2 Consultation with and involvement of NRAs -- 10.2 Improvement of WHOPAR awareness and usage -- 10.3 Improvements to the readability, quality of information, structure and layout of the PILs -- 10.4 Avoidance of stigmatisation -- 10.5 Product-related PI improvements -- 10.6 WHOPAR and PQTm-related recommendations -- 11 Conclusions -- 12 References -- 13 Annexes -- 13.1 Annex 1: Questionnaire WHOPAR -- 13.2 Annex 2: Questionnaire on acceptance levels of dispersible tablets -- 13.3 Annex 3: BALD scores of the evaluated 28 PILs -- 13.4 Annex 4: Individual EQIP scores of the 28 evaluated PILs -- List of tables -- List of figures.

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Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2024. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.