[e-drug] Innovation but slow uptake of improved pediatric ARV formulations

e-drug
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E-DRUG: Innovation but slow uptake of improved pediatric ARV formulations
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Dear E-Druggers,

BMC Pediatrics today published a new study describing the market evolution of pediatric ARVs. The study shows that much progress has been made in the development and production of better-adapted, fixed-dose combination ARVs for children, but global uptake has been slower than anticipated. A better understanding of barriers to uptake is needed to ensure new technologies reach those in need and to ensure manufacturers remain engaged in formulating low-demand medicines. Please find the abstract pasted below, and full article available open access at:

http://www.biomedcentral.com/1471-2431/10/74/abstract

We welcome your comments,

Brenda Waning
bwaning@bu.edu

Abstract (provisional)

Background

Important advances in the development and production of quality-certified pediatric antiretroviral (ARV) formulations have recently been made despite significant market disincentives for manufacturers. This progress resulted from lobbying and innovative interventions from HIV/AIDS activists, civil society organizations, and international organizations. Research on uptake and dispersion of these improved products across countries and international organizations has not been conducted but is needed to inform next steps towards improving child health.

Methods

We used information from the World Health Organization Prequalification Programme and the United States Food and Drug Administration to describe trends in quality-certification of pediatric formulations and used 7,989 donor-funded, pediatric ARV purchase transactions from 2002-2009 to measure uptake and dispersion of new pediatric ARV formulations across countries and programs. Prices for new pediatric ARV formulations were compared to alternative dosage forms.

Results

Fewer ARV options exist for HIV/AIDS treatment in children than adults. Before 2005, most pediatric ARVs were produced by innovator companies in single-component solid and liquid forms. Five 2-in1 and four 3-in-1 generic pediatric fixed-dose combinations (FDCs) in solid and dispersible forms have been quality-certified since 2005. Most (67%) of these were produced by one quality-certified manufacturer. Uptake of new pediatric FDCs outside of UNITAID is low. UNITAID accounted for 97-100% of 2008-2009 market volume. In total, 33 and 34 countries reported solid or dispersible FDC purchases in 2008 and 2009, respectively, but most purchases were made through UNITAID. Only three Global Fund country recipients reported purchase of these FDCs in 2008. Prices for pediatric FDCs were considerably lower than liquids but higher than half of an adult FDC.

Conclusion

Pediatric ARV markets are more fragile than adult markets. Ensuring a long-term supply of quality, well-adapted ARVs for children requires ongoing monitoring and improved understanding of global pediatric markets, including country-based research to explain low uptake of new, improved formulations outside of UNITAID and what can be done to accelerate children's access to HIV/AIDS care. A close dialogue is needed between clinicians making selection and prescribing decisions, supply chain staff dealing with logistics, donors, international organizations, and pharmaceutical manufacturers to better match country-based demand with global supply and donor policies.

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E-DRUG: Innovation but slow uptake of improved pediatric ARV formulations (2)
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Dear all,

I would like to underscore the need for increased research efforts to
develop appropriate pediatric formulations that is also highlighted in this article.

For many years, the lack of easy-to-use pediatric formulations for some
antiretrovirals have hindered efforts to scale up HIV/AIDS pediatric
treatment. Appropriate pediatric formulations are still lacking for a range of important ARVs, and are still not adapted for use in resource-limited settings. Limited research has been conducted in children with HIV/AIDS to assess the safety and efficacy of ARVs, and fewer ARV treatment options exist for infant and children as compared to adults. The lack of pediatric research is particularly relevant for newer ARVs.

The lack of simple pediatric dosages is a contributing factor to the
insufficient pace of scaling up of pediatric treatment in developing
countries, and renewed research and development efforts are still needed.

With best regards,
Elodie

Elodie Jambert
Pharmaceutical Coordinator
Médecins Sans Frontières (MSF)
Campaign for Access to Essential Medicines
Tel: +41 22 849 89 45
elodie.jambert@geneva.msf.org

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E-DRUG: Innovation but slow uptake of improved pediatric ARV formulations (3)
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Dear colleagues,

The frightening lack of appropriate paediatric formulations and delivery systems is a worrying matter in wider health care programmes, and not just at paediatric stage. We recently had a 2010 brief from CHAI on the paediatric ARV global situation, which was very informative and is recommended information to colleagues working in this area. I think there are two things to deal with, experience / practice and research.

I still come across many instances where the prescriber will ask whether this six year old can take a capsule or tablet. That picture says a lot about healthcare providers' own (lack of?) knowledge about what formulations and presentations are available to them. That situation then translates into a behaviour and practice that becomes set against new and improved formulations, even when these new presentation are made available to programmes.

The issue about more research in this area of paediatric formulations is important: It would be nice to know what exactly is being researched into in regard to paediatric formulations, and who is carrying out research? Is here an idea about the cost of this research, and how is that research to be financed? There are issues about the global size and value of the paediatric ARV 'market' and whether that is sufficient to drive interest to research in this area. But it may be possible to create that interest, if other pharmaceutical products that are currently not 'child- friendly' are package together for researching new paediatric and child- friendly formulations.

Regards,

Bonnie

Bonface Fundafunda PhD., MBA., B.Pharm
Manager, Drug Supply Budget Line
Ministry of Health,
P.O. Box 30205,
Ndeke House,
Lusaka,
Zambia
Tel: +260 211 25 41 83
Fax: +260 211 25 33 44
Mobile: + 260 979 25 29 00
Email: bcfunda@hotmail.com

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E-DRUG: Innovation but slow uptake of improved pediatric ARV formulations (4)

Dear professional colleagues

Please find below excerpts from a literature review on how health care innovations spread and why they often do not. The summary highlights some aspects to be considered if the innovation can have an important impact or whether it is adopted

(Acknowledgement, Nancy Binkin, UNICEF).

See Wikipedia description on diffusion of innovations http://en.wikipedia.org/wiki/Diffusion_of_innovations

I am not an expert in diffusion of innovation theories and practice but I believe what is needed at this stage in the process of seeking better medicines for children is some understanding of rates of adoption and adopter categories. We may well find that our "slow pace" is not slow at all or that we need to target a different category of adopters if we want to increase the rate of adoption.

Many of the aspects outlined below have already been taken into account, but they are worth a revisit as we continue to seek more age appropriate formulations of medicines for children.

Relative advantage
Is the new approach more more effective than the current strategy? Is it more cost-effective? If it is not perceived to
have an advantage, it could be dead in the water. Having an advantage does not guarantee adoption. This benefit needs to be clear to the adopter- and the benefit to the adopter might well be different from the perceived benefit to management or to the promoter of the approach

Compatibility
Is it compatible with user's values, norms, ways of working, and perceived needs?

Complexity
Simple is good! If it is complex, can it be broken down into smaller bites? The perception of complexity can also be partly overcome with demonstrations and hands-on experience.

Trialability
Is there space given to try it out on a limited basis?

Observability
Are the effects of the innovation readily observable?and preferably measurable

Reinvention
Is there room to adapt it to local realities or to refine it? This seems particularly important for dissemination of "good practices" spread through horizontal networks

Fuzzy boundaries
(related concept)
Having a fixed core of common elements, but with other elements that can be adapted around the edges to meet different circumstances and needs.

Risk
If there is a high degree of uncertainty in adopting the new approach, then it can be perceived as personally risky and thus it is less likely to be adopted especially in a risk-averse environment.

Task
issues
If a new approach is relevant to user's work and improves their performance, it is more likely to be adopted, especially if it is feasible and easy.

Ease of transfer of knowledge
from one context to another

Augmentation
support
Help desk, training, customization.
An implication of this seems to be that incremental changes are easier to promote than radical ones - since they fit more easily into existing norms and values and the benefit can apear more tangible, even if the potential improvement is less. At the same time just because and idea is easier to spread, it doesn't mean that it is better. There are some interesting trade-offs here between ideas that can be easily implemented and spread and those which might have a more profound impact.

Kind regards

Atieno Ojoo

Technical Specialist, Pharmaceuticals
Focal point, Better medicines for children
UNICEF Supply Division
Copenhagen, Denmark
alternate email: aojoo@unicef.org
atisojoo@yahoo.co.uk