Oxytocin is a lifesaving drug - it is one of the 13 commodities on the list of the United Nations Commission on Life-Saving Commodities for Women and Children. - See more at:
Oxytocin is temperature sensitive and in several countries studies have demonstrated that the product has lost some, to most of its potency by the time it reaches the women who need it most (those that give birth in remote areas.) In many cases this can be attributed to exposure to high temperatures during transport or storage (e.g. in clinics without air conditioned storage rooms)
On the other hand in some peripheral health centers oxytocin is stored in the cold chain and midwifes assure that it is available in the delivery room by putting it in the cold boxes they use for storing vaccines such as VAT and BCG. However, if the oxytocin has reached the health center outside of the cold box the product may have lost some or all of its potency.
What would be the dis-advantage of assuring that oxytocin is included in the cold chain from the point of entry of the country till it reaches the delivery room? Are there any countries who currently have oxytocin in the cold chain?
Please share your experience and thoughts.
Thank you,
Michel
PATH
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:
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.
Oxytocin leads call to expand Vaccine Cold Chain to other medicines. I think that this debate on Oxytocin in the Vaccine cold-chain is very important. Oxytocin is the first temperature sensitive medicine to receive serious global-level attention to the feasibility of sharing cool storage with vaccine. This question comes at a time when the supply and distribution of temperature-sensitive medicines for non-communicable diseases, such as insulin for diabetes, is undergoing expansion at orders of magnitude, far greater in absolute capacity than vaccine. Whether these medicines are regulated for storage at controlled room temperature (+15C to 25C) or for refrigeration standard (+2c to +8C) it is clear that temperature control will be needed at each step of distribution in parallel to vaccine. The design of each country system, the level and extent of integrated features will vary according to each country situation.
The pace of integration will depend on how issues such as the following are decided and how confident system managers can be in compliance and quality:
Ideally, the same type of refrigerator could be used either for vaccine or for medicines to simplify re-allocation of stock between appliances. The storage requirement will in most cases justify separate refrigerators for vaccines and medicines.
Answering these questions and I’m sure you have more, will require country by country assessment, negotiation and regulation but in the meantime, some practical steps at global level are needed to provide an ‘enabling’ environment in which shared cold chain is identified as an option. These suggestions are in addition to those listed in post 18 03/02/2014 Lydon.
WHO and UNICEF have come out with a clear statement about including cold sensitive commodities such as oxytocin in the cold chain. Please see:
http://www.unicef.org/health/files/EPI_cold_chain_WHO_UNICEF_joint_statement_A4_rev2_5-14-15_(3).pdf or attachment.
Hopefully this will contribute to better practices and safe lives
Michel