E-drug: 18th Expert Committee Meeting on Selection and Use of Medicines
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Dear e-druggers
The unedited report of the 18th meeting of the WHO Expert Committee on
Selection and Use of Medicines has been published today. This email
contains a summary of the report which can be found at:
www.who.int/medicines/publications/unedited_trs/en/index.html
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Summary of the report of the 18th meeting of the WHO Expert Committee on
the Selection and Use of Essential Medicines
The 18th meeting of the WHO Expert Committee on the Selection and Use of
Essential Medicines took place in Accra, Ghana on 21-25 March 2011. The
purpose of the meeting was to review and update the WHO Model List of
Essential Medicines (EML) as well as the WHO Model List of Essential
Medicines for Children (EMLc). Meeting participants are listed in Part
1 of the report, together with their declarations of interest.
In accordance with its approved procedures
(http://apps.who.int/gb/archive/pdf_files/EB109/eeb1098.pdf), the
Committee evaluated the scientific evidence on the comparative
effectiveness, safety and cost effectiveness of medicines to update the
WHO Model List of Essential Medicines and the Model List of Essential
Medicines for Children. In so doing, it:
* approved the addition of 16 new medicines to the EML
* approved the deletion of 13 medicines from the EML
* approved new indications for 4 medicines already listed on the
EML
* approved the addition of a new dosage form or strength for 4
medicines already on the EML
* rejected 9 applications for the addition of a medicine to EML
* approved the addition of 16 new medicines to the EMLc
* approved the deletion of 15 medicines from the EMLc
* rejected 3 applications for the addition of a new medicine to
the EMLc
Some of the main recommendations made, in order of their appearance on
the Model List of Essential Medicines, were:
* Section 6: addition of artesunate + amodiaquine combination
tablet for the treatment of malaria in adults and children, in line with
current WHO treatment guidelines. In making its decision, the 2011
Committee reviewed the latest clinical evidence and the information
about licensing in several countries of the fixed dose combination
tablet. The Committee noted, that appropriate doses of both medicines
can also be achieved using combinations of the mono-component products,
including as co-blistered presentations.
* Section 10: addition of tranexamic acid injection for the
treatment of adult patients with trauma and significant risk of ongoing
haemorrhage. On the basis of the results of a very large trial of the
use of tranexamic acid specifically for trauma patients - including
those who have been in road traffic accidents, the Committee concluded
that there is sufficient evidence to support the proposal that listing
tranexamic acid may contribute to a reduction in this cause of death.
* Section 18.5 : addition of glucagon injection, 1 mg/ml to treat
acute severe hypoglycaemia in patients with diabetes, to support efforts
in many countries to ensure appropriate treatment of the increasing
number of patients with diabetes. The Committee also recommended that
careful attention be paid to the cost of procuring glucagon and noted
that based on the experience with other high cost medicines, such as
antiretrovirals, inclusion in the EML may help to contribute to a
reduction in prices.
* Section 22.1: addition of misoprostol tablet, 200 micrograms
for the prevention of post-partum haemorrhage, where oxytocin is not
available or cannot be safely used. WHO guidelines currently recommend
that in situations were oxytocin is not available, misoprostol can be
used to prevent and treat post partum haemorrhage due to uterine atony.
Based on the evidence provided to it, the Committee considered that
misoprostol can be safely administered to women to prevent post-partum
haemorrhage by health workers trained in its use in the third stage of
labour. The addition of misoprostol for the treatment of post-partum
haemorrhage was not approved. The clinical trials that compare
misoprostol to oxytocin in women who need treatment for post-partum
haemorrhage show that misoprostol is not as effective as oxytocin. In
addition, there is no evidence to support the safety and efficacy of the
800-microgram dose for treatment of post partum haemorrhage when given
to women who have already received prophylactic misoprostol 600
micrograms orally. Countries need to work to make oxytocin available for
treatment of women who are bleeding after delivery and misoprostol
should only be used if there is no other option.
Other medicines that were added to the Model EML are: isoflurane,
propofol, midazolam, clarithromycin, miltefosine, paclitaxel and
docetaxel, bisoprolol, terbinafine cream/ointment, mupirocin
cream/ointment, and atracurium.
The Expert Committee did not approve the following proposals for
addition of medicines on the basis of the evidence submitted: ether,
gatifloxacin, a fixed dose combination of isoniazid+ pyridoxine+
sulfamethoxazole +trimethoprim (because there is no marketed product),
etravirine, darunavir, raltegravir, dihydroartemisinin + piperaquine,
pyronaridine+artesunate, loperamide. The Committee suggested that if
the applications for some of these medicines could be updated to resolve
the uncertainty about comparative effectiveness and safety, an extra
session of the Committee might be convened before the next scheduled
meeting to re-evaluate them.
The Expert Committee also assessed a review of the comparative
effectiveness and cost-effectiveness of analogue insulins compared to
recombinant human insulin. The products considered were: insulin
glargine, insulin detemir, insulin aspart, insulin lispro, and insulin
glulisine. The Committee noted that while many of the comparative
trials find a statistically significant difference between analogue
insulins and standard recombinant human insulin for some effects on
blood glucose measurements, there is no evidence of a clinically
significant difference in most outcomes. The Committee concluded that
insulin analogues currently offer no significant clinical advantage over
recombinant human insulin and there is still concern about possible
long-term adverse effects.
A summary of reasons for all changes to the List is in Section 1 of the
report. All applications and documents considered by the Committee will
remain available on the website for the meeting at
http://www.who.int/selection_medicines/committees/expert/18/en/index.htm
l.
The next update of the WHO Model List of Essential Medicines will take
place in 2013.
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Deirdre Dimancesco
Technical Officer
Medicines, Access and Rational Use
Department of Essential Medicines and Pharmaceutical Policies
World Health Organization
20 Ave Appia, 1211 Geneva, Switzerland
dimancescod@who.int
+41 22 791 4560
www.who.int/childmedicines