Lisa Hedman Henrik Nielsen World Health Organization UNICEF Technical Briefing Sessions

1. Progress on activities recommended by UN Commission on Life Saving Commodities for Women and Children Lisa Hedman Henrik Nielsen World Health Organization UNICEF Technical Briefing Sessions October 2013, Geneva photos courtesy of Lisa Hedman unless otherwise noted.

2. “Each year, millions of women and children die from preventable causes. These are not mere statistics. They are people with names and faces.” - UN Secretary-General Ban Ki-Moon • Photo: Dr Charles Senessie, AEMRN The objective is to identify and resolve the bottlenecks that limit access to health products that could save their lives

3. Objective:Identify, resolve bottlenecks for neglected RMNCH products • Lack of alignment across WHO – National EML – treatment guidelines – training materials • Medicines not registered or on markets after listing on the EML • Almost all commodities imported • Poor/absent post-market surveillance • Frequent stock outs due to problems with quantification, budgeting, parallel and vertical supply chains • Health workers not receiving updated treatment guidelines • Need to task shift and decentralize • Poor demand/utilization of some services (FP) • Financial access barriers

4. 13 commodities that would save lives if access was improved 13 commodities that would save lives if access was improved

5. 10 recommendations from the UNCoLSC to achieve sustainable access

6. Approach to increase access to life-saving commodities and services • Country Plans to increase access to commodities and services • and • Accelerate achievement of • MDGs 4 & 5

7. Recommendations in action Customized approaches for each commodity to be discussed in plenary in the next 10 Q and A slides

8. 1. Global market shaping for Contraceptive Implants • Implants are on EMLs, registered and available on many local markets. Supply in most countries is limited to international donor procurement, and there is only one quality assured manufacturer. While uptake rates are increasing, costs are prohibitive and training is required to support insertion and removal. What would be the most effective intervention to support a stable and realistic global market? • Pooled procurement mechanisms • Advance market commitments • Technical assistance to manufacturers • Training of providers • All of the above

9. 1. Best answer: bAdvance market commitments • Pooled procurement may be possible in the longer term, but an immediate solution is a higher priority. • Global supply is limited to few manufacturers who keep prices high. Negotiations to lower pricesthrough advance market commitments are most relevant for long term access and competion by new suppliers. • Training to providersand technical assistance for local supply can be useful, but since uptake was noted as increasing, addressing price and a non-competitive market are more urgent.

10. 2. Local market shaping for Emergency Contraception • Levonorgestrel(0.75 and 1.5 tablets) is registered, procured, and on local market in many countries, including locally and internationally supplied products. Use is limited due to misperceptions, price of on-patent products, and limited awareness that the product is available. What would be the most effective intervention to support a stable and realistic local market? • Pooled procurement mechanisms • Advance market commitments • Technical assistance to local manufacturers • Awareness campaigns to pharmacists, prescribers, communities • All of the above

11. 2. Best answer: dAwareness campaigns to pharmacists, prescribers, communities • Pooled procurementrisks disruption of a market without addressing the issue of demand. • Advance market commitments and technical assistance could ultimately help in improving supply…but if providers and the community are unaware or lack appropriate information, the existing supply may not even be sustainable. • Supply exists and may have some challenges, but the instability of demandis the larger risk to a stable supply and require awareness campaigns.

12. 3. Innovative Financing Mechanisms • For this recommendation, work is in progress to develop a performance-based funding mechanism • To date, what has been developed is an approach to harmonize across various RMNCH funding streams, and then fill gaps. The commodities would be among the priority gaps • Pathfinder countries have received a proposal for feedback and discussion

13. 4. Quality strengthening for dispersible amoxicillin • Dispersible amoxicillin would provide a flexible option to treat paediatric pneumonia; however, the dispersible product is limited in availability and the market overall is flooded with products of questionable quality. In addition, there is interest in shifting Rx authority to community case management. What are the best approaches to ensure a safe product? • Prequalification of all amoxicillin worldwide • Short term approval of qualified products (ERP) for procurement • Pharmacovigilence plans to support proposed task shifting • Support to local manufacturers • b, c and d (most of the above)

14. 4. Best answer: eMost of the above • There are thousands of amoxicillin formulations on the market and a PQ process for all would be impractical. • Short term quality review and approval the ERP brings the dispersible product to users quickly, while PQ is underway. • Where a less medically supervised environment is proposed, a rigorous PV and follow up plan is critical, especially for an antibiotic. • Some manufacturer will need technical assistance with quality and PQ processes to ensure longer term sustainability.

15. 5. Regulation and policy efficiency for misoprostol • Misoprostol is an option for post partum hemorrhage when oxytocin is not available. It is not authorized on many national markets due to its potential for use for abortion and falls to illicit markets. What approaches would ensure market authorization and availability? • Update National EMLs to include the PPH indication • Consider harmonized reviews, joint factory inspections to reduce the time and costs of entry to national markets • Provide a pharmacovigilence plan, especially for countries where use has been limited • Support to local manufacturers • a, b, c and d (all of the above)

16. 5. Best answer: eAll of the above • The product is not likely to shift in the market without clear policy guidance via the EML. • Agreement on dossier content and joint inspections reduces the number of processes for achieving market authorization across multiple countries. • The product has been frequently unavailable or has quality concerns of a black market, and should have PV support. • Some manufacturer will need technical assistance with quality and PQ processes.

17. 6. Supply and awareness for magnesium sulfate injection • Magnesium sulfate is the preferred treatment for pre-eclampsia and eclampsia, but less-effective and riskier medications, such as diazapam and phenytoin, are still used by health care workers, which limits demand to manufacturers. What intervention to support supply and awareness of MagS04 injection in local markets? • Training to generate demand and quantification of need to inform the market • Approaches to simplify administration such as single use packaging • Technical assistance to manufacturers • Advance market commitments • a and b

18. 6. Best answer: ea and b • Improving awareness and supply mechanisms will build a sustainable level of availability. • Ease of administration would support demand generation. • Technical assistance needs appear limited at this time and it is a simple product to make. • Advance market commitments would only disrupt existing supply chains.

19. 7. Demand and utilization for ORS • ORS is among the most effective treatments for diarrhea; however, studies have shown poor demand, preferences for antibiotics, and poor understanding of the benefits of ORS. What intervention to increase use of ORS would be effective? • Training and sensitization through a "behavior change and communication" campaign targeting both providers and communities • Make the product more palatable • Technical assistance to manufacturers • Advance market commitments

20. 7. Best answer: eTraining and BCC for providers and communities • To reduce both the demand by patients (mothers) and the response by prescribers, a BCC campaign will be needed. • While optimizing the taste could help in the long run, the larger issues of preference for other products is more urgent. • Technical assistance is a limited priority as the product is simple to make and there are numerous sources. • Advance market commitments would only disrupt existing supply chains.

21. 8. Reaching women and children • Reducing financial barriers to access will be important in the long run, and will require multiple responses. • This recommendation is linked to the planning for recommendation 3 on innovative financing. • Plans remain in development, and comments and discussion are welcome.

22. 9. Performance and accountability for injectable antibiotics • Injectable antibiotics are often under-used because treatment information is not consistently available to health care workers. Some products are known to have serious negative side effects if used incorrectly, e.g., gentamycin. What intervention to increase use of injectable antibiotics would be effective? • Training and sensitization through a "behavior change and communication" campaign targeting both providers and communities • Address out of date guidelines and identify approaches to reach the broadest number of health care workers • Provide training tools, supervision checklists, and mobile or other applications to improve access to appropriate information • b and c

23. 9. Best answer: db and c • BCC approaches would be insufficient and community would not be an ideal target for a complex Rx product. • Updating guidelines through evidence-based processes is a critical step in supporting rational and safe use. • Updates check lists, supervision, and trainingare needed to ensure that guidelines reach HCWs.

24. 10. Innovation for Oxytocin injection • Oxytocin is projected to prevent 41 million postpartum hemorrhage cases and save 1.4 million lives, but often has quality problems, including lack of adequate Active Pharmaceutical Ingredient. It also must be supplies in a cold chain. What would be the most effective intervention to support innovation of Oxytocin? • Integration into the vaccine cold chains • Non-parenteral inhalation/ intranasal spray-dried (dry powder) • Thermo-stable oxytocin formulation • Technical assistance to manufacturers • a, b, and d

25. Best answer: a, b and d • Integration into vaccine cold chains would require careful work and planning, but could be effective. • Nasal administration product exists although would need a significant training plan for health care workers. • Heat stable product is a long term process with significant investment required. A short term solution is imperative. • Technical assistance to manufacturers is needed to resolve quality problems.

26. Many thanks