[e-drug] Is South Sudan at high risk of bad quality medicines? (4)

e-drug
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E-DRUG: Is South Sudan at high risk of bad quality medicines? (4)
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Dear all,

I feel compelled to respond to this ongoing discussion.

I was among the very first persons to offer to South Sudan my experiences
and expertise in setting out what we thought at that time would install and
instruct good pharmaceutical services partly on voluntary basis. I think we
achieved a lot in one or two years. I am saddened but not surprised if
there is a down trend. I remember we wrote the pharmaceutical policy,
training curriculum, draft laws, essential medicines list, the distribution
of medicines guide etc. I still have all this on my shelf.

We must understand the intricacies between trade, politics and public health especially in regard to pharmaceuticals. My experience in public, pharmaceutical manufacturing industry, and currently consultancy services in pharmaceutical quality system reveals to me a lot needs to be done. It is a complex sector to resolve issues even in well established economies. It requires a determined and focussed approach. The most important thing I foresee at the moment is to understand the current situation. What is not being said, what are the undertones. The solution rests in the ability if a common approach, putting the various institutions together on a forward move, and realizing the balance between bureaucracy, delivery of services and quality. It is important that we put the act together.

The views expressed hear are personal and not of the institutions I work.

wow

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E-DRUG: Is South Sudan at high risk of bad quality medicines? (5)
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[Thank you so much to Stephen for this! The moderator particularly subscribes to this: "I was particularly impressed by some hosts who honestly pointed out and strongly cautioned us against borrowing their bad practices if South Sudan is to build a better pharmaceutical system".]

Dear e-druggers,

I always find a cocktail of speculations, political innuendos and vanity interesting and stimulating. Having spent close to five years in South Sudan, I’d like to add some close-up facts to the mix to put this discussion into perspective.

1) Is South Sudan moving backwards?
I think this is a question that is not best answered in a court of public opinion. Facts are there to prove the country has indeed made some strides, even if these have not come in leaps and bounds as some people might expect. I think Boniface captured the reality and/ challenges involved very well.

In the case of South Sudan things have indeed moved from draft policies and laws to tangible legal and regulatory instruments that are finalized and being implemented e.g. the national drug policy was promulgated in 2007; a Bill to establish an autonomous national drug regulatory (NRA) was passed by the Legislative Assembly and now await presidential assent; regulations/ guidelines are in place for controlling imports/ licensing of pharmaceutical operators; annual private sector inspections are conducted by MOH. In 2008, WHO donated 5 Minilabs kits to MOH and worked with Global Pharma to train MOH staff on their use; USAID funded MSH through the SPS program to support MOH operationalize pharmaceutical inspections, including Minilabs at two points of entry (POEs) so far. Arrangements are in place for external reference testing at accredited labs e.g. the WHO pre-qualified Kenya National Quality Control Lab, and recently USP. These QC arrangements are not just on paper, but have actually been used in the past to guide decisions in the interest of patient safety.

2) Is importation of pharmaceuticals regulated at all?
Public sector procurements have in-built rigorous QA requirements in the tendering process, which in the past screened out even some reputable international suppliers who fell short. MOH has clear guidelines for importation of medicines. These include restricting importation to licensed entities; requiring importers to obtain a verification certificate prior to shipping products to South Sudan; adopting “proxy drug registration” to screen products allowed for importation; subjecting consignments of medicines to document review, physical inspection, sampling for QC testing. However, these requirements/procedures are not implemented or respected at all times by all, especially the private sector, and even some INGOs. Thorough POE inspections are also only possible at the POEs where MOH has functional offices and assigned personnel.

3) Are borders adequately controlled?
Not really. So far, MOH has only functional inspection/ Minilab testing offices at two points of entry (Kaya and Juba). MOH staff are yet to be deployed to other designated POEs like Nimule, Nadapal,Serentenya, Kajo-Keji, and the Northern/ Ethiopian borders. However,sensitization/ orientation have been done for custom officials at these POEs on procedures/ requirements for importation of medicines, from where MOH often gets notified when medicines are discovered. This is obviously an area for improvement, which MOH and key stakeholders are aware of and trying to address.

4) Are partners providing any support?
Yes, but the question should really be: is this support appropriate or adequate? Over the years many partners have played their part, and this needs to be acknowledged. I was quite impressed by what Dr. Wanyanga and the team had done by 2006. WHO through its HSS program in South Sudan has been a key ally of the MOH too (I hope Dr. Besrat will readthis ….her passion for pharmacy is still well remembered here). PSF did some good work, especially in strengthening the pharmaceutical systems for NGOs in the public sector. Euro Health was contracted by MOH and played a key role too. The World Bank through the Multi-Donor Trust Fund (MDTF) as well as UNDP and UNICEF have all been involved in supporting the pharmaceutical sector. MSH through funding from USAID has implemented a unique approach of embedding technical advisors within MOH to mentor government counterparts and improve governance of key pharmaceutical departments. Pharmacists in the private sector have been keen and collaborative on ensuring good laws and regulations are developed and implemented.

So, is this adequate? No. The country requires more technical and financial support to strengthen pharmaceutical systems and regulations. However, South Sudan is best suited to people who are ready to get their hands dirty. A consultant who comes here expecting to order people around to achieve results will leave hugely disappointed.

5) What are the key challenges?
Details on challenges will require a full essay. However, in brief, it is paramount the NRA is quickly established and empowered since enforcement capacity for various pharmaceutical regulations is very low. Human resources (both numbers & skills) are limited yet there are no training institutes in the country for pharmacy cadres and the curriculum that is yet to be implemented needs a second look to ensure it is really responsive to the problems on the ground. Infrastructure is poor e.g. no Quality Control Lab yet results take long when samples are sent out. More work needs to be done on regional collaboration and information sharing; for a young nation, there is no need to reinvent the wheel.

Moving this discussion forward, I believe focus should really be directed towards generating ideas on how to strengthen pharmaceutical regulatory functions and collaboration in Africa as a whole. Last year, I was part of a delegation from South Sudan that visited three African countries to learn from their experiences in setting up and managing successful pharmaceutical systems. While we witnessed great achievements garnered over the years, we also noted a lot of commonalities between the nascent country and its sisters in Africa in areas of weaknesses. I was particularly impressed by some hosts who honestly pointed out and strongly cautioned us against borrowing their bad practices if South Sudan is to build a better pharmaceutical system.

For those living in a glass building, and who might need more reason to collaborate, think about this: South Sudan is landlocked meaning any counterfeit medicine in South Sudan definitely passed through one or two countries to reach here. Is it possible for these medicines to reach South Sudan without any leakage in transit? Finally, could counterfeit/ sub-standard medicines be an instrument of war or terrorism?

Best regards,
Stephen Mawa
C/o MOH, Minsterial Complex,

Juba, Republic of South Sudan
stmawa@aim.com