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Table 2 Participants’ opinions on challenges/shortfalls in the NEMLC and their processes

From: Selection of essential medicines for South Africa - an analysis of in-depth interviews with national essential medicines list committee members

Issue

Comment

Communication processes

“I think one of the weaknesses in the committee is communication. They do communicate to the provincial people but the provincial people then don’t always circulate it around. It is sent to all health sciences faculties but then maybe it just dies in the Dean’s office and doesn’t get sent around. When people give comment, feedback is seldom given to the individual commentators. Actually you know you can’t expect the secretariat to do everything. But the committees recognise that communication back to people on the ground is an issue. Our main message of communication in a way is the book, especially the primary care book. There’s a road show to provinces where new changes are highlighted and explained and then the book is launched. There’s a team from DoH that goes down to each province to explain that. So they try hard but it’s always hard to get down to the hundreds of thousands of health care workers on the ground but that’s the process”. (2003–2012)

“The way of disseminating information is cumbersome and essentially goes to depots and pharmacists rather than directly targeting prescribers, which is a problem”. (1998–2012)

“This has been one of the biggest challenges, I think. The movement of information from the EML committee to the end users is something we’re working hard on. It’s an extremely difficult task because there’s so many role players involved. There have been problems and complaints from provinces that the decisions are taken and no insight into why certain decisions are being made. There’s very little opportunity for feedback and when there’s feedback given there’s very little feedback on the feedback. So, the committee have taken up publishing rationales for every decision. Those are available on the website, and can be circulated to people with queries, explaining what the rationale was for a particular decision, reviewing the evidence base, doing the cost analysis, etc.” (2013)

“The communications between clinical advisors and pharmacist is robust”. (1998–2012) (exception)

Health economic expertise

“So there is a lack of health economic expertise in the country. And within the committees there are people with extra training in health economics and with good insight into it. But we do not do formal health economic analyses on anything. We don’t have the time or the personnel to do that. But as I said earlier, we don’t just look at cost; we try and express cost per quality adjusted life year. We use the rough world bank, WHO figure. That one to three times per capita GDP per QALY is something to be considered. More than three is too much, under one is good. But it’s not formal. It’s more a rough estimation to see whether we’re in the ball park rather than a formal process. It would be great if we had the resources of NICE but we don’t. But we do aspire to it. So there are only a handful of people with skill in the country. The EML keeps them all busy all the time and the EML has no budget for this. So we see it as crucial but lack the expertise”. (2003–2012)

Lack of Health economic information

“All of those were considered if the information was available. So anyone of those, whatever information, because there often isn’t information on this particular subject although it’s considered important, in my latter days it’s considered even more important as these disciplines were becoming more evolved. But there was always insufficient information, but all of the criteria that you considered; they are all methods that were used if the information was available”. (1998–2012)

“The answer is no because first of all there are many pricing considerations in the public sector which are not relevant to international environments. So international cost effectiveness, or shall we say pharmaco-economic studies are very rarely directly applicable to the South African environment. Again in the South African literature there have not been many publications of pharmaco-economic evaluations as they pertain to the public sector”. (1996–2012)

“So one of the problems is that these types of studies are very rarely available. The pricing committee put out guidelines for conducting pharmaco-economic studies. So the government have tried to facilitate the publication thereof. So although I said no we don’t use them, we would love to use pharmaco-economic evaluations that are appropriately targeted to the South African environment if they were readily available to us. We do look at international studies but usually the international pharmaco-economic evaluations we use as a basis for constructing our own, so that we don’t have to reinvent the wheel but we rarely just take one without adapting it to the South African environment”. (1996–2012)

Outcomes monitoring and evaluations

“So I think what I would say is, we aspire to that however the capacity in the country at the moment does not support that but basically we have fantastic pharmaco-vigilance policies, as you know KZN has won partner, spent millions of Rands on pharmaco-economic incentives and those sort of things” (1996–2012).

“At the moment people will give you answers as we think about it, but the reality is that the fantasy is not met. And also remember at the national level we would be reliant on provincial competencies then and that’s going to be very difficult. And one of the things that I lament all the time is, if you are sitting in graduation at the universities and you look into all the funny thesis that people do, you wonder whether or not they’ll fit in South Africa because there’s very little, ever, in academia or in our provinces where anyone ever looks at outcomes. So basically we are very reliant on international publications. Obviously if you get a local publication we get very excited but they are very very rare”. (1996–2012)

“The only internal data that we have readily access to, again because we haven’t been collecting it, because it’s not a South African tradition to do so, is the information on the drug utilization, essentially. We basically have dispensing data, which is becoming more detailed and of higher quality but that really addresses issues of affordability more than anything else. And some questions of equity when you find a medicine is being used in one area and not being used in another”. (1998–2012)

“The only mechanisms I recall at the time was to ensure that all prescribers had copies of the EDL and although this was not done within government itself you had NGO’s running courses in drug supply management including prescribing and dispensing. I think a lot more could have been done internally. I think this was a weak point on the part of the government at the time we established the EDL”. (1996)

“So the monitoring and evaluation of EMLs is problematic. DURs, that’s a major problem, that’s a flaw. So we do ABC analyses and all that, but there’s a flaw, we don’t really know if it’s been used properly and what the DUR has done. So it’s a major issue. DURs is not done at this moment in time. And that certainly needs attention”. (2003–2012)

“It is a process I have criticised internally and externally as being short on review of its impact and whinge on process, they keep on doing the same thing again and again but I think people are starting to accept that we may need to look a bit harder at impact rather than just development”. (1998–2012)

Roles and responsibilities of Committees

“I think there’s quite often confusion between the delineation of the National Essentials Medicine List committee and that of pharmaceutical services….generally there’s confusion about the role and responsibilities of the two”. (1996–2012)

Aligning processes – selection and procurement

“It became clear that there has not been much interaction between the process of selection and that of procurement. Quite often they will decide to select a medicine based on efficacy and even cost without looking at how widely available it is. We have dozens of patients on treatment, failing the course, yet the medicines are supposed to be good but it’s not readily available. And when you start putting patients on the medicine, then you have shortages and patients lapse and so on. I would say that even up to a few years ago, there has not been a strong link between selection and procurement”. (1996)

“I don’t know if it’s called a policy but they do have a SOP in place now to address medicine product shortages. They have a formulary against which you check to see if the product is on tender etc. but the whole process is unclear. It’s not like a policy; it was just like a circular that was sent around. There is a problem at present with transition in tender and there are currently huge medicine shortages”. (PTC, 2013)

Challenges with paediatrics

“One thing is, being a paediatrician and knowing that it’s a particularly difficult issue with paediatric drugs passed… they are a particularly vulnerable group of patients. My personal opinion is that paediatrics needs its own Standard Treatment Guideline process because it’s very different. Children should be prioritised not adults, according to the constitution. So I think those two are important aspects. I think the committee focuses on a lot of adult guidelines that isn’t the same and demands huge evidence burdens which isn’t available for children and which might result in lack of availability for children”. (2013)