Table 1 The expanded availability framework matrix for MA medicines
Pillar | Condition | Key indicator | Source/verification | Assumptions |
|---|---|---|---|---|
Registration and quality assurance | Quality-assured (and other) products are registered and have correct MA indications on label; Products include: • Co-packaged mifepristone (1 × 200 mg) and misoprostol (4 × 200 mcg) • Misoprostol 200 mcg • Mifepristone 200 mg | Number of products registered Names of market authorization holder | List of registered products OR Certificate of registration/licensing | Product must be registered for use; Multiple registered products increase competition and coverage |
Medical indications Quality and accuracy of product label Convenient packaging | Product inserts/label (instructions for use) Packaging/ Presentation | Format and instructions for use influence actual usage | ||
Quality-assurance status—Stringent Regulatory Authorities, WHO Prequalification, UNFPA Expert Review Program | Product registration details or manufacturer licensing documents | Standards are sufficient to ensure quality; Manufacturers are complying with standards; Regulatory agency procedures outlined are sufficient to evaluate product quality | ||
Policy and financing | Institutionalization of MA products and services in key national policy documents and guidelines Training and dissemination of policies and guidelines Commitment of public or private funds to procure products and provide services | Combination pack and/or individual drugs are: • On National EML and/or National Formulary (NF) • On National procurement list • Included in treatment guidelines | EML National Formulary; procurement list Treatment guidelines | Combination pack on EML or NF, procurement list drives procurement and availability |
Decreasing unsafe abortion is part of national strategy for MNH improvement | Maternal Health National Strategy Key informants | Key national policy documents establish the groundwork for programmatic plans | ||
Protocols for MA are in national medical/treatment guidelines and pre-service/in-service training curricula Mechanisms to disseminate information on MA MoH approved training plans and/or job aids | Standard/National Treatment Guidelines Emergency Obstetric Guidelines Training curricula | Appropriate and detailed guidelines are necessary to ensure safe use of MA Protocols influence practice Curricula are important for provider education | ||
Designation of funding for MA commodities in national budget/commodity budget | MoH annual budget/commodity budget | Government designates a budget line; Donor provides funding; Funds are allocated and disbursed when needed; Funds sufficient to cover product need, as defined by MoH strategy | ||
Procurement and distribution | Total product procured and distributed by public and private sector meets national need Affordable pricing | Public sector/NGO/private procurement of QA-assured or other combi-pack • Volume procured and sold/distributed • Distribution channels • Cost—wholesale and retail • Forecasting tool used • Product in procurement tenders Sufficient budget allocated | Central Medical Stores records Distributor/importer procurement and sales records Pharmacies | There is public/private sector procurement Forecasting tool used and is accurate Products are purchased through tenders or special orders |
Stock-outs (public, private, NGO): • Reported/observed stockout per sector % of zonal stores that experienced a stockout of product at any point during the past year | Central/regional/district/medical stores data Medical Stores reports MoH programmatic plan CMS reports; Key informants | Public sector procurement is supposed to cover all public sector need Public facilities rely on consistent stock at zonal store level | ||
Provider knowledge | Product is institutionalized in provider training curriculums Medical providers at appropriate levels of care know about product and can provide services | Knowledge of MA, products and policies Ability to provide MA services according to guidelines | Provider interviews; Service Provision Assessments | Drugs and equipment needed to provide service |
Safe abortion guidelines and job aids Providers trained using these guidelines | Provider interviews/facility visits/surveys | Guidelines include MA | ||
End-user knowledge and behaviour | Women of reproductive age know about safe abortion/MA and national policy/law | % women of reproductive age that know about MA and safe abortion policies | Country-specific surveys and studies | If women know product’s uses, utilization will increase |