[Le rapport "non publié" du 18éme comité d'experts sur la sélection et
l'utilisation des médicaments essentiels de l'OMS qui s'est réuni du
21-25 mars 2011 au Ghana se trouve à cette adresse web :
http://www.who.int/selection_medicines/Complete_UNEDITED_TRS_18th.pdf
ci-dessous un résumé des travaux.
CB]
UNEDITED REPORT OF THE 18th EXPERT COMMITTEE ON THE SELECTION AND USE OF ESSENTIAL MEDICINES
21 to 25 March 2011
Accra, Ghana
WHO Technical Report Series (UNEDITED REPORT -- 10 May 2011)
Executive summary
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. This was the
first meeting of the
Committee held outside of Geneva. 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). The Expert Committee Members and
Temporary
Advisers who participated in the meeting are listed in 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 Expert 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.
The Expert Committee:
¡ª approved the addition of 16 new medicines to the EML;
¡ª approved the deletion of 13 medicines from the EML;
¡ª approved new indications for 4 medicines already listed on the EML;
¡ª approved the addition of a new dosage form or strength for 4 medicines
already on
the EML;
¡ª rejected 9 applications for the addition of a medicine to EML;
¡ª approved the addition of 16 new medicines to the EMLc;
¡ª approved the deletion of 15 medicines from the EMLc;
¡ª 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,
were:
¡ª 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, however, that appropriate doses of both medicines can
also be
achieved using combinations of the mono©\component products, including
coblistered
presentations.
¡ª 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 ¡ª
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.
¡ª Section 18.5: addition of glucagon injection, 1 mg/ml to treat acute
severe
hypoglycemia 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 the antiretrovirals, inclusion in the EML may help reduce prices.
¡ª 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 there is no other
treatment
available, misoprostol can be used to prevent and treat post©\partum
haemorrhage due
to uterine atony. New evidence submitted to the Committee shows that
misoprostol
can be safely administered to women to prevent post©\partum haemorrhage by
traditional birth attendants or assistants trained to use the product at
home deliveries.
Misoprostol should not, however, be used to treat haemorrhage unless there
is no
other option available (see below). Moreover, if it is available, oxytocin
is
recommended as it is more effective and cheaper.
Other medicines that were added to the Model List 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 and misoprostol tablet for treatment of post©\partum
haemorrhage.
The Expert Committee also assessed a review of the comparative effectiveness
and costeffectiveness
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.html.