By John Wiernikowski, ISOPP Advocacy Task Force Chair
After last years participation in a Union for International Cancer Control (UICC) sponsored program on Impact of Drug Shortages and Quality on Patients with cancer in which ISOPP members Bo Yu (China); Irene Weru (Kenya) and Annemeri Livinalli (Brazil) participated; our activity (not by choice) took a downturn.
We await (the highly anticipated) publication of our next set of Standards of Practice. Once the Standards are published, the Advocacy Task Force will work with UICC on an audit to identify which standards are not being met, or are being met with difficulty, in various countries around the world. Once identified, the Task Force will work with UICC and its partners to help institutions worldwide meet the standards.
This year is also a year in which the WHO re-evaluates the WHO Essential Medicines List (EML). I have been in contact with Dr. Lorenzo Moja at the WHO EML Secretariat having had the opportunity to meet him in person in 2019. As a result of that meeting, I am pleased to report on two significant developments in our relationship with the WHO. Firstly, after the 2019 WHO EML list update, there was virtually no uptake of oncology drugs by low and middle income countries (LMICs). The major barrier being identified as cost. As a result of this, WHO recognized and acknowledged that drug affordability was a key factor affecting the EML. The strategy that WHO came up with to address is to link the WHO EML (for cancer drugs) with standardized treatment regimens for resource limited settings. The pediatric oncology community has been doing this for more than a decade now through the International Society for Pediatric Oncology (SIOP). Efforts to do this in the adult context have been sporadic. WHO is in the process of producing a Cancer Manual for LMICs. This manual will have standardized treatment protocols for specific cancers, as well as supportive care guidelines that will be linked to drugs listed on the EML. Our Task Force by virtue of ISOPP’s diverse membership and having pharmacists from LMICs has been specifically invited to participate in the development of this Cancer Manual by providing input into the standardized treatment and supportive care protocols.
Secondly, the list of proposed addition of new drugs as well as changes in indications for existing drugs to this years WHO EML was published in April and had (seems traditionally) a short time window for interested parties to submit comments on the EML additions/changes. Despite the tight timeline, our Advocacy Task Force pharmacists stepped up to the challenge. Within a week, all had read some or all of the oncology drug submissions and those from LMICs identified key drugs and issues which would likely see these drugs not translate to their national essential medicines lists/formularies. A number of oncologic drugs were identified, all with cost implications being a major deterrent to adoption in LMICs. Additionally, we identified measurement of methotrexate levels being listed as an intermediate priority for LMICs as a significant issue for re-prioritization. We identified writing teams; Irene Weru (Kenya) and Mario Sobreira (Brazil) for the oncology drugs, and Annemeri Livinalli, Brooke Bernhardt (USA) and myself for the methotrexate level issue. Task force members supplied writing teams with key narratives, national realities and references. We managed to get through 4 iterations of the oncology drug comment and 3 for the methotrexate levels in 4 days…amazing! I took on the task of re-editing the documents after each iteration for final submission. We had both in the inboxes of the EML Secretariat Chair and Dr. Lorenzo Moja for the morning of May 21st.
After a week I received very exciting news. Our submissions were very gratefully received, and the points made in our submissions were felt to be very valuable, so much so that we have been invited to make an in person (well in person virtually) statement to the WHO EML secretariat on June 21st when final deliberations on this years WHO EML will conclude.
We have also been given the heads up that UICC will be approaching us again in the near future for some further programs that they are planning. We have also been approached by SIOP to participate in a global oncology drug quality/pharmacovigilance initiative. More (hopefully) news on these in an upcoming newsletter.
Are there advocacy initiatives that you can think of that our Task Force should be engaged in? Let us know in the upcoming ISOPP Members survey.
John Wiernikowski, PharmD, FISSOP, FCAPHO
ISOPP Advocacy Task Force Chair