Success: WHO adds co-packaged ORS and Zinc to its Essential Medicines List

Our application* to get co-packaged ORS and zinc on the WHO Essential Medicines List has been successful. This is game-changer. It moves ColaLife’s work out of the ‘innovation box’ into the mainstream of global children’s public health – with better designed, easier-to-dispense diarrhoea treatment available for sick children – potentially everywhere. A summary of the WHO decision is here.

The WHO Essential Medicines List (EML) is a model list designed to be adopted by national governments. As national governments adopt the list, this impacts on policy change and on funding in each country – and globally. Action on the ground follows policy.

The application was initiated by ColaLife and implemented by the Diarrhoea Innovations Group (DIG). ColaLife is a member of DIG and was a driving force behind the application. Aside from contributions from the ColaLife team (Simon Berry, Rohit Ramchandani and Jane Berry), seven other authors also contributed to the application.

This change will increase demand for our experience and learning in Zambia – and we are ready to respond. People can look at the resources on this searchable blog – especially those gathered here: colalife.org/resources – or they can contact us in person. ColaLife is currently writing a ‘Play Book’ based on the Zambia experience that will guide others who wish to introduce or scale-up co-packaged ORS and zinc in their own countries.

The cascade from the WHO EML to national EMLs can take some time; not all countries will necessarily follow the WHO lead. To help speed this process up and make the adoption as wide as possible, PATH will be leading an initiative to ensure global awareness of this change to the WHO EML and encourage adoption by national governments.

You can help immediately by sharing this blog post using the buttons at the very end of this blog post.

Onwards and upwards.

 

* The application was put together and submitted by the Diarrhoea Innovations Group (DIG). It was initiated and led by ColaLife’s Simon Berry and joined by many organisations across the global health space. This effort would not be possible without all the partners involved – not least the other nine authors – thank you!

 

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Postscript: This has been a long journey for ColaLife and our collaborators. Here’s a summary timeline:

Feb-17 (2 years 3 months ago)
Simon Berry engaged with Dr Nicola Magrini (WHO EML Secretariat) regarding a late submission to the 2017 EML Committee for the inclusion of co-packaged ORS and zinc on the WHO Essential Medicines List. Dr Magrini said that we were too late but if we could get an application in, he would try and get it included in the agenda. He indicated that the application would carry more weight if it came from the Zambia Ministry of Health.

25-Feb-17
The Zambia Ministry of Health submitted a last-minute proposal to the EML Secretariat in an attempt to get co-packaged ORS and zinc considered by the 20th EML Expert Committee which sat in Mar-17. This was written by Simon Berry (co-founder of ColaLife), Jane Berry (co-founder of ColaLife) and Rohit Ramchandani (ColaLife’s public health adviser). However, we had not followed the correct process and our proposal was not considered. We would have to resubmit for the next meeting of the EML Committee in two years time (2019).

10-Mar-17
Blog post by Simon Berry on the ColaLife website: Why isn’t co-packaged ORS and Zinc on the WHO Essential Medicines for Children?
Which provoked this tweet from the ex-Deputy Director of CARE Zambia:

27-Mar-17
Blog post by Simon Berry on the ColaLife website: Making the Case for Inclusion of Co-packaged ORS/Zinc on the WHO Model List of Essential Medicines for Children (EMLc)

26-May-17
Simon Berry met with Dr Per Ashorn of the Mother, Child and Adolescent Health Unit at WHO Geneva to discuss a potential application to get co-packaged ORS and zinc on the WHO Essential Medicines list for Children. Per was encouraging and offered support for the idea. He indicated that his team might put in a parallel proposal for the same thing.

7-June-17
Blog post by Simon Berry on the ColaLife website: Update: Co-packaged ORS/Zinc on the WHO Essential Medicines List for Children (EMLc)

12-Sep-17
Simon Berry gave a presentation to the Diarrhoea Innovations Group (DIG) making the case the for group to get behind a submission to WHO to get co-packaged ORS and zinc on the Essential Medicines List for Children. The presentation was prepared by Simon Berry, Rohit Ramchandani and Jane Berry. DIG needed time to consider this as they had not engaged on policy issues before.

6-Nov-17
Rohit Ramchandani met face-to-face with selected DIG members in Baltimore to further make the case for DIG to support an application to WHO.

8-Nov-17
Bonnie Keith confirmed that PATH would help with the application using their success at including a new indication for oxygen in the EML and EMLc in 2017, identifying oxygen as a medicine essential for the management of hypoxemia.

1 to 18-Dec-17
Simon Berry developed the first workplan for this initiative and sent it to DIG members.

19-Dec-17
Becky Castle sent a list of possible funders for the application effort.

20-Dec-17
Simon Berry completed Unorthodox Philanthropy draft application for funding (which was ultimately unsuccessful).

22-Dec-17
Jane Berry precis’ed Unorthodox Philanthropy application for funding.

27-Dec-17
Simon Berry wrote and submitted the Unorthodox Philanthropy application via Becky Castle.

2-Jan-18
Email from Inon Schenker (DIG co-chair) requesting a further presentation to DIG members interested in engaging with the application.

3-Jan-18
Simon Berry made a second presentation to DIG members who were potentially interested in engaging with the application.

15-Jan-18
David Shultz informed DIG members of PATH’s application to Takeda for funding to support this initiative.

17-Jan-18
Conference call to discuss funding proposal to Takeda.

18-Jan-18
Rohit Ramchandani met with Grand Challenges Canada (Karlee Silver) and as part of that meeting let them know we were seeking funding for the EML Application. Karlee Silver requested more information following the meeting and the Unorthodox Philanthropy application was sent to her as a concise statement of our plans. Unfortunately, GCC did not ask for a full proposal.

22-Jan-18
Elena Pantjushenko (PATH) corrected the description of the oxygen application within the Unorthodox Philanthropy application before it was sent to Karlee Silver.

17 to 25-Jan-18
The group work collaboratively on the funding bid to Takeda which was to include kit distribution in Zambia. The bid was submitted to Takeda on 25-Jan-18.  Ultimately, this funding application was not successful.

6-Feb-18
Elena Pantjushenko shared information on the process they had followed with their successful application to get Oxygen on the WHO EML in 2017.

6-Feb-18
DIG call coordinated by Becky Castle: funding update; WHO liaison; review of workplan; stronger engagement from DIG members despite no funding in place.

6-Mar-18
DIG call coordinated by Becky Castle.

15-Mar-18
Inon Schenker (co-chair of DIG) shared a 2-page description of our proposed work to submit an application to the WHO EML Secretariat which he proposed be sent to CIFF, UNITAID and Elma Philanthropy.

26-Mar-18
Lorenzo Moja confirms to Elena Pantjushenko that DIG would be able to the submitting entity for our application but emphasises the need to follow the WHO framework for applications and for applications to be evidence-based.

26-Mar-18
Simon Berry commits to merging the nascent application in Google Docs into the WHO Framework and also suggests that we design our application so that it is resilient to changes in future ORS and Zinc recommendations. In the ORS space there is already variation in sachet size (200 mL, 500 mL and 1L) and there may be changes in the future with regard to Zinc eg dosage. The recommendation of 20mg may well change and there is already ambiguity on the duration of treatment (10-14 days) and some say 5 days is enough. He suggested that the application should not get into anything already covered by the existing entries for ORS and Zinc. For example, when it comes to issues such as safety we should focus on the safety issues related to co-packaging (only) not the safety issues associated with ORS and Zinc and co-packaging as these are, and will be, covered by the existing listings for ORS and zinc in the Essential Medicines List.

28-Mar-19
Becky Castle published the assignments agreed for developing the different sections of the application.

28-Mar-18
Elena Pantjushenko set up shared area on Box (an online document sharing and editing platform) to enable joint authoring of the application and requested that ColaLife share their 2017 ORS/zinc submission (see entry for 25-Feb-17 above).

29-Mar-18
Simon Berry added WHO Guidance Notes to the application as comments and rationalised other comments on the draft application. He also updated section headings to meet the WHO requirements for applications.

30-Mar-18
Simon Berry completes a line by line review of the first seven sections of the application on Box and asks others to comment and contribute.

19-Apr-19
Elena Pantjusheko invited Camilla Horwood (Boehringer Ingelheim) to Box Group and confirmed that the assignments for PATH staff had been updated and that the PATH contributions to the first draft were on track to be complete by 14-May-18.

19-Apr-18
Conference call organised by Becky Castle.

19-Apr-18
Dennis Adu-Gyasi (Kintampo Health Research Centre (KHRC), Ghana) committed to contributing “Annex 2: List of co-packaged ORS/zinc in the WHO Model Formulary (2008) and the Model Formulary for Children (2010)” as per the assignment list.

20-Apr-18
Simon Berry reviewed the application on Box to remove all comments that had been dealt with and all notifications of minor changes. He also provided detailed instructions to the group of how to use Box.

20-Apr-18
Elena Pantjushenko reported on a conversation with Matt ?? (PATH’s point of contact for WHA activities) regarding possible engagement with WHA 2018 and WHA 2019. This engagement did not happen.

27-Apr-18
Simon Berry had a pre-arranged Skype call with Dr Per Ashorn (WHO) who indicated he was leaving WHO at the end of Jun-18 and suggested we meet face-to-face with relevant colleagues at WHO before that. Dr Ashorn shared a letter he had written to the WHO EML Secretariat on 10-Mar-18 on behalf of the MRD team in the Department of Maternal, Newborn, Child, and Adolescent Health (MCA) to request co-packaged oral rehydration solution (ORS) and zinc to be included in the EMLc, for children with acute watery diarrhoea. The EML team had responded saying applications needed to be presented using the WHO Framework. Dr Ashorn confirmed that his team would not be putting in a parallel proposal (see 26-May-17) as first thought but instead would support our application.

27-Apr-18
Becky Castle, Mark Grabowsky and Rohit Ramchandani communicate on how to source ORS/zinc pricing information.

13-May-18
Catherine Clarence offered to reach out to Ghana contacts for information on ORS/zinc.

16-May-18
Ibrahim Khalil (University of Washington) confirmed that he was making good progress with Section 8: Information supporting the public health relevance.

18 to 21-May-18
Annie Clark worked on section 10.

22-May-18
Gwen Ambler (Clinical Research Officer, PATH) started her work on Sections 7 of the application. Gwen also contributed to most of the other sections.

5-Jun-18
Becky Castle confirms the timings to the release of the first draft of the application to WHO for comment.

6 to 7-Jun-18
Simon Berry and Becky Castle review and tidy up the draft document prior to sending it to WHO for comment.

7-Jun-18
Elena Pantjushenko initiated the review of the draft application by PATH staff.

12-Jun-18
Simon Berry wrote first draft template letter of support.

13-Jun-18
Gwen Ambler undertook final edits of her sections prior to the release of the first draft.

13-Jun-19
First draft of application circulated to potential call participants by email by Elena Pushjushenko and Simon Berry.

13-Jun-18
Conference call to discuss first draft of application arranged by Becky Castle and Elena Pushjushenko and chaired by Simon Berry.

15-Jun-18
Simon Berry emailed WHO with the objectives for the meeting of 25-Jun-18 and proposed a draft agenda.

16-Jun-18
Simon Berry added WHO Guidance Notes as comments of the section headings in the application.

17-Jun-18
Simon Berry undertook a significant revision of the application on Box and listed inputs required from others.

22-Jun-18
Simon Berry incorporated Lorenzo Moja’s (WHO) and Bernadette Cappello’s (WHO) comments into the application and made other edits.

25-Jun-18
WHO Meeting in Geneva.
Simon Berry and Phillipe Guinot from PATH Geneva met with Per Ashorn and Jonathon Simon (both from the MCA Unit at WHO) and Lorenzo Moja (EML Secretariat) at WHO Geneva with Rohit Ramchandani participating over Skype. The purpose of this meeting was to discuss and receive feedback on the first draft of our application.

3-Jul-18
Comments and contributions to the application by Simon Berry.

4-Jul-18
Becky Castle sought letter of support from UNICEF. This was ultimately successful.

Jul-19
Contributes/comments by Jaclyn Delarosa (PATH).

17-Jul-19
Conference call organised by Becky Castle.

17-Jul-18
Simon Berry issued an action point list following the meeting to help ensure momentum was maintained.

20-Jul-18
Elena Pantjushenko edited the template letter of support and created a template email to send to those who we would like letters of support from. Elena also asked for clarification about whether we were going for an addition to the EML as well as the EMLc. Simon Berry suggested that we remain focussed on the EMLc as this has been our focus up until now and this was the basis of our meeting with WHO on 25-Jun-18. Simon Berry also suggested tweaks to the support letter template and covering email template.

25-Jul-18
Elena Pantjushenko and Philippe Guinot (PATH Geneva) started liaison with PATH’s country offices in Africa to get letters of support from Ministries of Health.

25-Jul-18
Becky Castle sent reminders to the team regarding the letters of support and reviewed Sections 12 and 13 of the application.

27-Jul-18
Blog post by Simon Berry on the ColaLife website: Update 2: Co-packaged ORS/Zinc on the WHO Essential Medicines List for Children (EMLc)

27-Jul-18
Simon Berry emailed a contact in MSF asking for the contact details for the right person within MSF to talk to about a letter of support. He finally identified the right person and ultimately MSF did provide a strong letter of support. See 21-Sep-18.

27-Sep-18
Blog post by Simon Berry on the ColaLife website: Zambia adds co-packaged ORS and zinc to Essential Medicines List

1-Aug-18
Eugenio de Hostos (PATH) contacted David Sack (formerly Executive Director of icddr,b, now Professor, Department of International Health, Johns Hopkins University Bloomberg School of Public Health) requesting a letter of support.

5-Aug-18
Simon Berry circulated action points for the DIG conference call of 31-Jul-18.

7-Aug-18
Jaclyn Delarosa (PATH) added comments and edits to the application.

8-Aug-18
Kate Schroder (CHAI) checked in and offered a letter of support from CHAI.

11-Aug-18
Contributions to the application by Simon Berry including adding comments from Jaclyn Delarosa.

13-Aug-18
Comments added by Bob Clark (PATH).

13-Aug-18
Simon Berry incorporated Jaclyn Delarosa comments and edits to the application on Box and dealt with simple questions posed by Jaclyn and fielded the others to Rohit Ramchandani, Elena Pantjushenko, Gwen Ambler and Becky Castle.

13-Aug-18
Elena Pantjushenko drafted a concept note describing our work. Becky Castle and Simon Berry commented.

14-Aug-18
Simon Berry re-designed ORS/zinc pricing table to resolve misinterpretation problem.

14-Aug-18
Becky Castle distributed an agenda for the meeting of 15-Aug-18 which included her draft of Sections 11 and 12, responsibilities for obtaining letters of support and the draft Concept Note.

14-Aug-18
Conference call organised by Becky Castle.

17-Aug-18
Contributions to the application by Rohit Ramchandani including summary of evidence table.

21-Aug-18
Elena Pantjushenko suggested that Simon Berry, Jane Berry, Becky Castle and Rohit Ramchandani meet virtually to go through pending issues with the application. This conference call went ahead on 24-Aug-18.

22-Aug-18
Elena Pantjushenko reviewed the application, locked it and passed it to the PATH proof reader.

24-Aug-18
Elena Pantjushenko, Simon Berry, Jane Berry, Becky Castle and Rohit Ramchandani meet virtually to go through pending issues with the application.

25-Aug-18
Simon Berry completed Annex III – the summary of the meeting with WHO on 25-Jun-18.

25-Aug-18
Elena Pantjushenko reported that she was gathering additional edits for inclusion.

27-Aug-18
Elena Pantjushenko called for missing references for section 8. Simon Berry supplied one. Rohit Ramchandani offered to supply the ones he had used.

28-Aug-18
Elena Pantjushenko asked Felix Lam (CHAI) a few questions including what credits to use for the images supplied by him.

29-Aug-18
Felix Lam responded with the answers to Elena Pantjushenko’s questions.

30-Aug-18
Elena Pantjushenko sent Ibrahim Khalil his section (Section 8) with outstanding questions. Ibrahim Khalil committed to return his revised section promptly.

31-Aug-18
Elena Pantjushenko uploaded a clean, proof-read version of the application to Box and listed outstanding issues and responsibilities.

4-Sep-18
Ibrahim Khalil provided his final input to Section 8a.

4-Sep-18
Annie Clark answered the outstanding issues in Section 10a and 13.

5-Sep-18
Felix Lam provided edits and answers to questions for Section 11 and Annexes. These were added to the application by Elena Pantjushenko.

5-Sep-18
Simon Berry requested that ColaLife’s role in initiating the application was acknowledged on page 2 of the application. This was accepted.

6-Sep-18
Rohit Ramchandani responded to outstanding questions on pages 21 and 25 of the application.

6-Sep-18
Simon Berry sent a clean copy of the application to WHO for final comment.

11-Sep-18
Elena Pantjushenko shared PATH’s Advocacy and Communications Plan with Rohit Ramchandani, Becky Castle and Simon Berry.

18-Sep-18
Elena Pantjushenko distributed a draft fact sheet on the application for use in the advocacy and communications work.

19-Sep-18
Simon Berry responded with comments on the advocacy and communications fact sheet and suggested that Olivier Fontaine as an advocate to recruit. This didn’t happen.

21-Sep-18
Simon Berry received a response from Christa Cepuch, Pharmacist Coordinator, MSF indicating that they would consider sending a letter of support after our application had been submitted. MSF did submit a strong letter of support – see 16-May-19.

26-Sep-18
Elena Pantjushenko started a dialogue on a possible post-submission communication and advocacy campaign and circulated the communications plan PATH used for their oxygen submission in 2016.

27-Sep-18
Blog post by Simon Berry on the ColaLife website: Zambia adds co-packaged ORS and zinc to Essential Medicines List

1-Oct-18
Simon Berry did a last read through and removed all format-related track changes in preparation for sending the application to the PATH proof reader.

9-Oct-18
Rohit Ramchandani sent comment on the advocacy and communications fact sheet.

14-Oct-18
Simon Berry added pictures of the co-packaged ORS/zinc products to the application.

15-Oct-18
Rohit Ramchandani completed his review of the application.

16-Oct-18
Elena Pantjushenko locked the file on Box and passed it to the PATH proofreader.

19-Oct-18
Edits received from the proofreader. These were dealt with by Elena Pantjushenko.

22-Oct-18
Becky Castle circulated a list of Letters of Support in hand and committed. She reported that she was chasing the outstanding letters including the ones from UNICEF and DfID.

22-Oct-18
Elena Pantjushenko released the proofread application on Box for final edits from Simon Berry and Rohit Ramchandani.

22-Oct-18
Elena Pantjushenko consulted on contacting all authors to check that they do not have any further final edits..Simon Berry suggested an approach to this that would minimise delays and this was agreed.

23-Oct-18
Conference call.

23-Oct-18
Simon Berry undertook final edits.

23-Oct-18
Becky Castle and Elena Pantjushenko finalised the list of authors and organisations consulted.

23-Oct-18
Simon Berry completed the Application Submission form which didn’t quite fit our proposal and consulted with Elena Pantjushenko, Gwen Ambler, Becky Castle and Rohit Ramchandani on this.

25-Oct-18
Gwen Ambler advised on how to complete the Application Submission form.

29-Oct-18
Letter of support received from UNICEF.

5-Nov-18
Elena Pantjushenko asked Rohit Ramchandani and Ibrahim Khalil to respond to questions raised by the PATH reviewers about Sections 8 and 9.

5-Nov-18
Ibrahim Khalil responded to PATH reviewer’s questions.

6-Nov-18
Rohit Ramchandani responded to PATH reviewer’s questions.

12-Nov-18
Simon Berry submitted the application to the WHO EML Secretariat by email cc’ing all WHO contacts. The application went in with 10 letters of support. WHO acknowledged receipt on the same day.

12-Nov-18
Blog post by Simon Berry on the ColaLife website: Application submitted to WHO to add co-packaged ORS and zinc to the WHO Essential Medicines List

19-Nov-18
Our application was published on the WHO EML website.

23-Nov-18
DfID letter of support received by the EML Secretariat.

25-Nov-18
Blog post by Simon Berry on the ColaLife website: DfID Secretary of State and UNICEF provide letters of support

7-Dec-18
Deadline for submission of applications for changes to the WHO Essential Medicines List. Our application had already been submitted and published by WHO on their website at this point.

13-Dec-18
Simon Berry contacted Lorenzo Moja with questions about the WHO processes following the passing of the deadline for submissions. At this point only two applications had been published on the WHO website.

14-Jan-19
Becky Castle called for a meeting with Elena Pantjushenko to discuss the schedule for post-submission blog posts.

16-Jan-19
Simon Berry wrote first post-submission blog post and sent to Becky Castle, Elena Pantjushenko and Rohit Ramchandani.

17-Jan-19
Rohit Ramchandani suggested changes to blog post.

21 to 23-Jan-19
Simon Berry, Rohit Ramchandani and Elena Pantjushenko finalised blog post.

31-Jan-19
Blog post by Simon Berry on the ColaLife website: Our EML application now open for comments on the WHO website

5-Feb-19
Elena Pantjushenko circulated updated post-submission communications plan.

6-Feb-19
Becky Castle compiled a contacts list for post-submission communications and circulated it for comments and additions.

12-Feb-19
First mass email sent by PATH informing stakeholders that the application had been submitted and was open for comment.

14-Feb-19
Elena Pantjushenko reported that two additional letters of support had been received (Phyto-Riker (GIHOC) Pharmaceuticals, a participant of the SHOPS project, and JustActions – Leith Greenslade). These were sent to the EML Secretariat on 20-Feb-19.

16-May-19
Blog post by Simon Berry on the ColaLife website: MSF writes letter of support for our application to get co-packaged ORS and zinc on the WHO Essential Medicines List

3-Jun-19
Simon Berry reported that WHO had published the Expert Reviews on the WHO EML website and that the review of our application had recommended inclusion of co-packaged ORS and zinc on the Essential Medicines List.

3-Jun-19
Elena Pantjushenko shared the ORS/zinc co-pack cross-DIG comms plan. Responses received from Simon Berry, Mark Grabowsky, Leith Greenslade and Felix Lam.

6-Jun-19
Elena Pantjushenko, Becky Castle and Simon Berry liaise on post EML publication communications plan.

9-Jul-19 at 10:30am CET
The revised Essential Medicines Lists were released by WHO and co-packaged ORS and zinc is included in both the main EML and the Essential Medicines List for Children (EMLc).

End