Key definitions
| Good Distribution Practices (GDP) | A WHO guideline that provides orientation for distribution of pharmaceutical products. Depending on the national and regional legislation on pharmaceuticals, these guidelines may apply equally to products for human and for veterinary use. The guidelines cover products for which a prescription is required by the patient, products which may be provided to a patient without a prescription, biologicals and vaccines.29 |
| Model Quality Assurance System for procurement agencies (MQAS) | A WHO guideline that provides detailed guidance to procurement agencies on quality assurance practices. |
| QUAMED Local Market Assessment (LMA) | An assessment, carried out by QUAMED experts on demand of QUAMED partner/s, of a convenient sample of pharmaceutical distributors and manufacturers operating in a given country, aiming to assess if WHO quality standards are met. |
| QUAMED MQAS audit | An audit of a pharmaceutical distributor / procurement agency that relies on the licences and marketing authorisation granted by the national regulator, and also has the potential to implement its own prequalification system for the product-manufacturer couple (ie, for preselecting suppliers and individual products). It is carried out by QUAMED experts on demand of QUAMED partner/s, and based on the WHO MQAS guidelines. It usually takes 2–3 days per distributor/procurement agency. |
| QUAMED GDP assessment | An assessment of a pharmaceutical distributor that relies on the licences and marketing authorisation granted by the national regulator and does not have the potential to implement its own prequalification system for the product-manufacturer couple (ie, for preselecting suppliers and individual products). It is carried out by QUAMED experts on demand of QUAMED partner/s as part of a LMA, and based on WHO GDP guidelines. It usually takes half-a-day per distributor. |
| MQAS QUAMED rating | A rating developed by QUAMED, based on the WHO MQAS, and aiming to rate each assessed activity in five different levels of compliance (0–4). In this study, we used the most recent version, revised by the QUAMED Technical Committee in 2019, and finalised on 28 August 2019 . |
| GDP QUAMED rating | A rating developed by QUAMED, based on the WHO GDP and aiming to rate each assessed activity in five different levels of compliance (0–4). In this study, we used the most recent version, revised by the QUAMED Technical Committee in 2019, and finalised on 28 August 2019. |
| MQAS/GDP level of compliance | A level of compliance attributed to each activity in the QUAMED ratings for MQAS and GDP, going from 0 (non-compliance or low compliance) to 4 (high compliance). Level 2 corresponds to the minimum acceptable requirement in terms of compliance. |
| Activity | For the scope of this study, an ‘activity’ indicates a specific area of pharmaceutical quality assurance (see ‘QUAMED ratings’). |
| Quality assurance (QA) criteria | For the scope of this study, a QA criterion is built by bringing together a group of activities with a similar or convergent scope (see ‘QUAMED ratings’). |
| Percentage of compliant distributors | For the scope of this study, this indicator was defined as the percentage (%) of distributors, out of all those included in the analysis, with an MQAS or GDP level of 2 or more. |
| Product-manufacturer couple | The process by which a pharmaceutical distributor should verify and evaluate a product dossier and the relevant manufacturer site documentation, as a condition to accept it for purchase. It is generally based on a risk assessment strategy |