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[e-drug] Artemether/ lumefantrine - pack sizes, brand name (9)

E-DRUG: Artemether/ lumefantrine - pack sizes, brand name (9)
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[On request of the moderator, Novartis responds to the recent discussion 
summarized by Rob Verhage on 29 July. E-drug would also welcome a response from 
WHO Roll Back Malaria. WB]

Response from Novartis Pharma AG Regarding Coartem Packaging

July 31, 2007

Subject: E-DRUG: Artemether/lumefantrine - pack sizes, brand name issue

Dear e-druggers:

On behalf of Novartis Pharma AG, I would like to respond to the number of 
inquiries posted on E-Drug regarding Coartem ® pack sizes and compliance.

At the time that Coartem® (Artemether/lumefantrine) was developed, it was 
understood that as with all anti-malaria treatments, compliance would be the 
key. Together with its partners, Novartis developed the Coartem presentation 
for the public market. The explicit recommendation of healthcare workers was 
that the medication should be provided together with very clear information on 
how to use the drug, i.e. with the instruction to patients provided as pictures 
rather than just written text. 

The effectiveness of giving instruction this way has been validated during 
rigorous field testing of the current presentation of Coartem 2. The results 
have been published in an article in The Lancet entitled: "Supervised versus 
unsupervised intake of six-dose artemether-lumefantrine for treatment of acute, 
uncomplicated Plasmodium falciparum malaria in Mbarara, Uganda: a randomised 
trial." (Ref. Lancet 2005; 365:1467-1473). 1 

To our knowledge, no other malaria treatment has undergone such rigorous field 
testing of a medicine for every day usage.  The authors of The Lancet study 
state that although it was not possible to show to what extent high efficacy 
was only attributable to the improved packaging itself, their findings strongly 
suggest that the mode of Coartem packaging favours high adherence 
(sealed-blister with visual depictions of when to take each dose appropriate 
for non-literate users).2  

These findings support the decision by Novartis to maintain the current 
presentation of Coartem for the public sector.  However, more importantly than 
finding logistical convenience is the fact that healthcare providers in 
malaria-endemic countries have a medicine which enforces compliance - which 
will be of greatest benefit to the patient.

Another advantage of the current presentation of Coartem is that in the vast 
majority of the rural health facilities, there are no dispensing pharmacists.  
In these cases, the healthcare worker dispenses a single blister card which 
contains the appropriate amount of medication based on the weight of the 
patient.  Thus, the patient/caregiver receives a discreet, single package of 
Coartem with a short explanation of how to use the medication, as opposed to 
receiving potentially multiple blisters or loose tablets in a plastic 
dispensing bag (with or without instructions). 

As to the concern that providing different dose strengths in different packages 
would make Coartem more expensive, this is not the case.  Novartis provides all 
Coartem medication to the public market without profit.  Donor funds are used 
to purchase the medicine and patients receive Coartem for free.  Whatever 
additional costs are incurred for preparing different presentations of Coartem 
is marginal compared to the benefit patients receive from this medicine.   

There is a legitimate concern that stock-outs of the different presentations 
force health care workers to sometimes mix and match the medication from the 
available stock to come up with the right number of tablets for the weight of 
the patient (e.g. cutting up the adult presentation for use in children). 
Changing the pack size will address the problem of stock-outs only partially, 
if at all. Most important is improving the logistics for distributing the right 
amount of medication in a country, not changing the packaging.  The Procurement 
& Supply Management Working Group of the Roll Back Malaria initiative is 
specifically targeting these objectives. Moreover, Novartis actively supports 
the efforts of various National Malaria Control Programmes to improve stock 
situations and logistics. 

To respond to the question about the brand name, Coartem, being used in a 
public market setting, we feel it is important for the patient to become 
familiar with not only the product itself (both the name and packaging), but 
also to identify the producer of the product as well, in order to be assured of 
good quality.   

In conclusion, to date, more than 100 million treatments of Coartem have been 
distributed to the public sector and the feedback has been resoundingly 
positive, especially from patients and health care providers. The current 
presentation of Coartem has proven its value in clinical practice by 
significantly improving patient compliance and saving patient lives.  The 
challenge for reaching more patients is to improve the supply and distribution 
of the medication rather than changing the packaging. . 

Regards,

Dr. Patricia Ibarra de Palacios
Principal Medical Scientific Expert,
Tropical Medicine
Novartis Pharma AG

References

1 Piola P, et al. "Supervised versus unsupervised intake of six-dose 
artemether-lumefantrine for treatment of acture, uncomplicated Plasmodium 
falciparum malaria in Mbara, Uganda: a randomised trial." Lancet 2005; 
365:1467-73

2 Fogg C, Bajunirwe F, Piola P, et al. "Adherence to a 6-dose regimen of 
arthemether lumefantrine for treatment of uncomplicated Plasmodium falciparum 
malaria in Uganda." Am J Trop Med Hyg 2004; 71: 525-30 

[submitted by: Bob Laverty - VP Communications
Malaria Initiatives
Novartis Corporation
608 Fifth Avenue
New York, New York 10020
Office:  212-830-2423
Mobile:  609-506-9693
bob.laverty@novartis.com ]

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