For those of you that haven’t had a chance to follow the latest discussion on IAPHL, I provided below a second recap of the discussions and some thoughts on next steps. Very best, Patrick.
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Dear IAPHL Friends,
Many thanks for those of you that have continued to participate in this discussion. As we enter the last week on this topic, I thought I would reflect on some of the additional points made, and solicit your inputs on how the international community of stakeholders could move this agenda forward.
[1] Some further reflections:
• Oxytocin potency loss risk
On the topic of potency loss, an interesting study from the New England Journal of Medicine was shared on the effects of freezing (http://www.nejm.org/doi/full/10.1056/nejmc1209761). The results show that the potency of Oxytocin is largely unaffected after being exposed to either (a) continuous freezing temperatures of ?5°C, ?20°C, on ice, and on dry ice for a period of 7 days, or (b) multiple cycles of freezing and thawing during a period of 5 days. The study concludes that health workers can be reassured that Oxytocin can be safely used in the event of accidently freezing in the cold chain either during storage or transportation.
This is a great advantage of Oxytocin over many of the new vaccines being used in EPI. Temperature monitoring studies have shown that 35% of EPI vaccines are exposed to extended periods of freezing in the cold chain. This is a real concern. Vaccines that lose potency from freezing represent about 70% of the value of vaccines procured through UNICEF (the main procuring agency for vaccines in the world). The more traditional EPI vaccines like Polio, need to be kept in freezing temperatures, and others like BCG and Measles can be frozen without loss of potency given that they come in a lyophilized (freeze-dried) presentation. Does this mean that Oxytocin should be kept with the EPI vaccines that are not freeze sensitive like Polio? Perhaps not. But it may mitigate the risk of confusing the products in the cold chain between only Polio and Oxytocin. It is something to think about? I could help justify where in the supply chain integration could happen.
• Cold chain capacity risk
On the topic of cold chain capacity, I didn’t pick up on any new insights on this. Instead, I would like to share some that relate to the Effective Vaccine Management (EVM) assessments that have been conducted by WHO and UNICEF in approximately 70 countries since 2010. The EVM assessment is essentially a continuous quality improvement process that is recommended to countries to ensure their vaccine supply chains meet minimum standards at all levels of the in-country system (national, sub-national and service levels) and according to 9 criteria (vaccine arrival, temperature control, storage capacity, quality of the infrastructure and it’s maintenance, vaccine management, distribution, stock management, LMIS…). A recent WHO analysis of the data from 65 low and lower-middle income countries revealed that only 1 country met all recommended standards at all levels of their supply chain. This is a key concern in EPI given that for vaccines, the state of the supply chain has numerous shortcomings. When considering Oxytocin in the vaccine cold chain, the state of the vaccine supply chain is something that needs to be considered very carefully.
• Implementation risks
While the first few weeks of discussion had a strong focus on the risks of potency loss from not having Oxytocin in the cold chain, and the risk that the vaccine cold chain isn’t planning necessarily for the capacity needs for such time and temperature health products, the past few weeks has seen more inputs on the implementation risks.
The main take home message is that there isn’t a one-size-fits-all solution. Implementing a strategy to include Oxytocin in the vaccine cold chain is not one that may be advisable in all setting and countries. A tailored approach will be needed and on a country by country basis. For the majority of countries that are not already implementing such a strategy, certain pre-conditions prior to implementation ought to be required and monitored to gauge country-readiness for such a policy change. In those countries that are implementing, additional tools and methods are most certainly required. And particularly to avoid any risk of confusion of products in the cold chain. The case of were the diluent for a lyophilized vaccine (BCG) was accidently used was cited as an example that led to a fatal outcome.
[2] Ideas for next steps:
So where does this leave us in moving forward? As we begin to close down this discussion, it would be good to reflect on where to go next, and to ensure that all the great inputs from the IAPHL community can be brought forward to those working on Oxytocin in the cold chain as part of the UN Commission on Life Saving Commodities. Although I know for a fact that many are tuned into this discussion even if they’ve been shy to join in.
Picking up on the ideas of many of you, I’ve bulleted below what can constitute the beginnings of a list of next steps forward. These are listed in no particular order:
- Document the specific experiences in countries that have already integrated Oxytocin in the vaccine cold chain (in settings where it has worked well and where it has not worked so well) to understand the reasons for doing so and understand what worked and what didn’t work. The ultimate idea is to draw lessons learned from selected countries that are already implementing a practice of Oxytocin in the vaccine cold chain
- Document the specific reported incidents where Oxytocin in the cold chain led to a bad outcome, and undertake the root-cause analysis.
- Conduct one or two pilot projects in countries to implement Oxytocin in the cold chain and fully evaluate the good, the bad and the ugly.
- Define the segments of the supply chain that could benefit from integration. In other words, should integration occur at national level and then vaccines/Oxytocin get split out into separate distribution chains between sub-national and service levels. Or should integration occur only at the last mile and not at national level? A mix between the two? The idea is to understand what model of integration would be advisable in what setting.
- Forecast the combined needs for EPI vaccines and Oxytocin for the next 5 years (or up to 2020 for example) against the available and planned capacity in the vaccine cold chain.
- Develop a framework for assessing country readiness to include Oxytocin in the cold chain.
- Develop a list of issues, risks and mitigation strategies of including Oxytocin in the cold chain.
- Work at global level on product presentation and packaging that can mitigate risk of confusion with vaccines.
- Develop global guidance and recommendations and work with normative agencies and partners at regional/country level to support policy change.
- Conduct training and capacity building activities to ensure a smooth change management for health workers in implementing a practise of Oxytocin in the cold chain.
This is certainly not an exhaustive list and we’d appreciate any further ideas, thoughts and inputs before we close the discussion at the end of the month.