Obstacles to making opioids available

1. Obstacles to making opioids available Meg O’Brien March 2013

2. The MORPHINE framework | Organize | Regulations | Procurement | Healthworker | Initiation | Nationalization | Empowerment Mindset Ensure that policy makers understand the issues and are prepared to take a lead role Consult stakeholders to map process and barriers to access Ensure that they are up-to-date or identify needed changes Establish budget for drug purchase, storage, and distribution. Estimate quantities, identify suppliers, secure product registrations, develop tenders, place and pay for orders, and receive and distribute to regional medical stores Organize awareness-raising activities, in-service training, and continuing medical education; develop reference materials and guidelines Establish pain treatment by trained clinicians, usually at large clinical centers or specialized clinical units Integrate into service delivery at regional and district hospitals and ensure adequate geographical coverage to make pain relief accessible to all who need it Create a sustainable stakeholder base

3. Armenia: 3 kg Competent authority submits annual estimate to International Narcotics Control Board (INCB) INCB approves morphine quantity MOH places order with registered supplier and competent authority applies for import permit from INCB Mechanism of access INCB compares order size to estimate and approves import license What does it take to get pain relief? Patient receives monitoring and follow-up Supplier obtains export permit from INCB Patient fills prescription Clinician asks about pain Product delivered to central stores Drug distributed to facilities Clinician writes prescription Patient reports pain

4. Where are the supply challenges? • Lack of registered suppliers for the right formulations • Cost or effort to register outweighs potential profit from registration • Low margins and low volumes • Lack of clarity about the appropriate mix of formulations that are needed • 10mg vs. 30mg vs. 60mg • Immediate release vs. sustained release Lack of sustainable budget for procurement • High prices • Lack of competition among local distributors • Erratic ordering makes it difficult for suppliers to plan efficient production and uncertainty drives up costs of production

5. Where are some options? • Work with suppliers to reduce initial investment or risk • Waive registration for first three years • Guarantee purchase volumes and payment • Create and share credible forecasts with suppliers • Plan orders with advance notice and regular deliveries • Coordinate procurement with other countries in the region • Harmonize packaging • Bundle negotiations and procurement • Negotiate a framework agreement • Foster competition among local distributors

6. Where are some options? • Use government pharmaceutical companies to produce • Use locally produced oral morphine solution while growing demand to create a healthy market for tablets • Less expensive (usually about 1/3 the cost of tablets): API (powder) is cheaper, registration usually not required • Longer shelf life • More flexibility with formulations: different dilutions can be made “just-in-time” and can be used for adults and children • Immediate release, so can be used for rapid relief, and can be used to titrate doses • Holding and distribution costs can be reduced • If production is done early in the supply chain, there is less opportunity for diversion and abuse as finished oral solution is considered less prone than powder or tablets