Réseau Pharmaceutique Œcuménique (EPN)

The EPN Access to Essential Medicines guidelines do not address issues beyond the control of church health services (CHSs), such as foreign exchange rates, storage outside the CHS system, patient poverty, number of pharmaceutical staff (for example, pharmacists available), and patient information from other sources (for example, advertising). Nor do the guidelines address issues that are beyond the remit of EPN to assist CHSs, such as access to transport, construction of stores, the CHS system in its entirety, the expansion of CHSs to serve larger populations, and the health service of a country in general. These areas are recognized as being important but are nonetheless beyond the remit of this particular project.

Please download:

• EPN Access to essential medicines guidelines [.doc 90KB] [.pdf 64KB]

Also see:

• EPN Access guidelines baseline research

The guideline approach

Three factors are fundamental to this approach:

1. The initial baseline study for each country that reveals the current level of compliance on each of the specific guidelines and provides an impact assessment tool.
2. The development of country-specific plans, owned by EPN members, to increase compliance in a specific country.
3. The transfer of knowledge to members in other countries to increase their capacity to carry out such work.

The impact of individual guidelines is cumulative and there is no specific prioritization within them. However, for access to be maximized, it is believed that all the specifics detailed by the guidelines need to be in place. Each country will have its own pattern of compliance and the importance of interventions will depend on country specifics. It is believed that, as countries are at different levels of compliance, the priority for intervention to increase compliance should reflect local circumstances and not an external priority list. Thus, in any particular country, a small intervention may 'top up' a particular guideline activity and therefore may be prioritized over a large intervention targeting another recommended guideline from start-up to compliance. For example:

• If 70% of hospitals with over 50 beds have working DTC committees then an intervention targeted on those 30% without committees may be prioritized over work to support the implementation of local community involvement in 100% of hospitals with more than 50 beds.
• A particular country could decide that work to get tax exemptions extended to CHSs would have a greater immediate impact than training hospital 'owners'.

The key to developing country-specific plans is the results from the baseline survey. These results will not only allow impact evaluation and monitoring but also provide information for decision making. 

Guidelines and their indicators 

1. Compliance with best practices for drug storage and management.
• Presence of check list for good storage conditions
• Percentage of stock outs
• % of expired medicines (in relation to average inventory value)
• Service level (% fulfilment of requested demands)
• Presence and use of bin or stock cards
• Regular calculation of minimum and maximum stock
• Presence of annual audit/inventory reports of drug store
• Presence of SOPs (procurement, receiving, issuing)
• Regular monitoring reports.
2. Compliance with rational use of medicines guidelines.
• No more than two indicators to be used from WHO guidelines for each of:
• Prescribing
• Dispensing
• Facility
• Patient care.
3. Functioning medical supply system.
• Structures—warehouse and stores
• Essential Drugs List (EDL) stocked
• Meets CHS needs for supply, cost, and delivery
• Low levels of wastage
• Availability of stock records
• Availability of standard operating procedures and evidence of implementation
• Procedure manuals or guidance for personnel and financial activities.
4. Functioning Drug and Therapeutics Committees (DTC) in hospitals.
• Membership defined
• ToR in place
• Regular meeting
• Date of last meeting
• Drug list adapted to needs
• Standard treatment guidelines in evidence
5. All 'owners' with maximum understanding or roles, best practice, and management information.
• Revolving drug fund concept: Understanding of concept and implementation of methods of increasing access for the poorest
• Rational use of medicines concept
• Essential drugs concept
• Management of HIV/AIDS—related demands
• Awareness of health and drug production in country
• Costing mechanisms for pharmaceutical services
• Sustainability of CHS concepts
• Strategic planning.
6. Implementation of standard operating procedures for procurement.
• Availability of SOP procurement document
• Self-assessment results of SOP audit.
7. Improvement in access to medicines for a facility, passed on to patients.
• Affordable prices
• Prices compared to other facilities
• Independent pharmacy budget
• List of exemptions.
8. Quality assurance policy in place and implemented.
• Structure in place to ensure compliance to registration standards
• Frequency of regulatory authority visits
• Written standard operating procedures
• Access to and usage of a quality control laboratory
• Compliance with national regulatory authority standards (or an appropriate alternative, such as WHO).
9. Pricing policies in place and operationalized.
• Documented pricing policy (formula and accounting process, and accounting for windfalls)
• Price list
• Implementation evidence.
10. Government subsidies extended.
• % trained personnel (pharmaceutical)
• % salaries paid by government
• % national health budget that goes to CHS for medicines (subsidised medicines received)
• Government contribution to infrastructure development.
11. Pro-poor ethic in evidence.
• Exemption policy
• Promotion of insurance schemes
• Differential pricing
• Advocacy activities
• For provision/subsidies for the poor.
12. Tax exemptions available to CHSs.
• Documentation of existing taxes (current government tax policy)
• List of current exemptions
• Documentation (application letters, acceptances and rejections).
13. Transparency mechanisms in place in support of 'Health for All'.
• Audited reports available
• Annual reports available
• Collective planning (annual, strategic) mechanism in place
• Policy on monitoring and evaluation written and implemented
• Organogram (professional profile)
• Staff recruitment policies written and implemented.
14. Effective community involvement system in place.
• Evidence of system
• Evidence of topics raised and actions resulting from the system
• Awareness levels of the local community of system.
15. Cross-facility information sharing.
• Evidence of information collected
• Evidence of information passed to other facilities, the government systems national drugs policy, and national health management information systems and within hierarchies.
16. Compliance with drug donations guidelines.
• Selection of three indicators from guidelines.
17. Mechanism in place to allow for representation at regional and national levels in relevant debates.
• Selection of three indicators appropriate for the local debate environment.
18. At least one pharmaceutically trained person per facility.
• Quantification of drug needs
• Drugstore management
• Quality assurance
• Rational use of medicines
• Unit costing
• Record and data management
• Appropriate financial management.
19. Access to key pharmaceutical information.
• Available in the pharmacy area:
• Essential Drugs List
• National (or WHO) formulary
• Standard treatment guidelines
• New and obsolete drugs list
• Registered drugs list
• Local production manuals.
• Available in the facility:
• National drugs policy
• DTC/PTC guidelines
• WHO essential medicines publications
• International medicines pricing indicators
• Rational use of medicines information
• Reports from CHSs on pharmaceuticals
• Managing drug supply manuals.
20. Regular assessment of pharmaceutical unit work.
• Annual reports of unit evaluation.
21. Church leaders' awareness of key messages.
• Comparison to baseline in three selected areas appropriate to the local environment.
22. Pharmaceutical function represented at all levels of discussion.
• Minuted discussions at various levels
• Interview results.
23. Disaster preparedness procedures in place (e.g., earthquake, flood, influx of refugees, conflict).
• Documentary evidence
• Review data of three selected indicators.