E-DRUG: 16th WHO Model Essential Medicines List
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[The WHO EML Expert committee met 23-27 March 2009 to discuss all
proposed changes to the 16th WHO Model Essential Medicines List. WHO
yesterday published the UNEDITED (not yet formally approved) version on
its website. There are some interesting decisions:
- Oseltamivir (Tamiflu) was rejected due to lack of evidence in avian
(!) flu. (Question: Will Dr Chan overrule the committee in view of the coming swine flu pandemic?)
- Misoprostol was added for incomplete abortion, etc
E-drug welcomes discussion on these changes. WB]
General webpage:
http://www.who.int/selection_medicines/committees/expert/17/en/index.htm
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New 16th EML:
http://www.who.int/selection_medicines/committees/expert/17/WEB_unedited
_16th_LIST.pdf
Additions, changes and deletions to the Model List
1. The Committee made the following changes to the Sections:
Section 6.3 and Section 6.5.2: The listing of liposomal amphoteracin B
was modified to specify both the deoxycholate and the liposomal form.
Section 6.2.2: Sulfadiazine was deleted from this section as it is only
indicated for the treatment of toxoplasmosis.
Section 6.5.4: Sulfadiazine was added to this section because it is only
used for the treatment of toxoplasmosis.
Section 18: Fludrocortisone was added to provide concordance with the
EMLc since it was noted by the Committee that it would be essential for
the treatment of congenital adrenal hypoplasia and adrenal failure in
adults.
Section 24.3: The term "sleep disorders" was deleted from the heading of
the section on the basis that there are specific epidemiological and
clinical differences between generalized anxiety disorders and sleep
disorders. The creation of a new sub-section for sleep disorders was not
deemed appropriate at this time as there were no specific medicines for
listing.
2. The Committee recommended the following additions to the Model List:
Section 5: Parenteral diazepam with a square box was replaced by
parenteral lorazepam, 2 mg/ml and 4mg/ml in 1 ml ampoule, with a square
box. The rectal solution or gel formulation of diazepam was retained on
the Model List.
Section 6.2.4: Addition of rifabutin capsule 150 mg with the note: for
use in patients with HIV receiving protease inhibitors. Rifabutin was
not added to the EMLc at this meeting because there was a lack of
evidence of its efficacy and safety in children.
Section 6.3: Addition of the liposomal formulation of ampotericin B.
Section 6.4.2.3: Addition of atazanavir 100 mg; 150 mg and 300 mg solid
oral dosage forms.
Section 6.4.2.3: Addition of heat stable fixed dose combination
formulations of lopinavir/ritonavir 100 mg + 25 mg and 200 mg + 50 mg
tablets.
Section 6.4.2.3: Addition of heat stable ritonavir 100 mg and 25 mg
tablets.
Section 6.4.2.3: Addition of saquinavir 500 mg tablet.
Section 6.5.5: Addition of nifurtimox 120 mg tablet with the note, only
to be used in combination with eflornithine for the treatment of
Typanosoma brucei gambiense infection.
Section 8.2: Addition of carboplatin as the representative platinum
compound, 50 mg/5 ml, 150 mg/15 ml, 450 mg/45 ml and 600 mg/60 ml
injection.
Section 8.2: Addition of hydroxycarbamide 200 mg, 250 mg, 300 mg, 400 mg
and 500 mg capsules and 1 g tablet.
Section 8.2: Addition of ifosfamide 1 g and 2 g vials of powder for
injection.
Section 8.2: Addition of mesna 100 mg/ml injection and 400 mg and 600 mg
tablets.
Section 12.2: Addition of amiodarone 50 mg/ml injection and 100 mg, 200
mg and 400 mg tablets to the complementary list.
Section 12.3: Addition of hydrochlorothiazide 12.5 mg tablet and 50 mg/5
ml oral liquid.
Section 17: Addition of omeprazole as a representative proton pump
inhibitor, 10 mg, 20 mg and 40 mg oral solid dosage form and 20 mg and
40 mg sachets of powder for oral suspension.
Section 17.2: Addition of ondansetron with a square box, 2 mg/ml
injection, 4 mg/5 ml oral liquid and 4 mg, 8 mg and 24 mg solid oral
dosage form.
Section 17.2: Addition of dexamethasone 4 mg/ml injection, 0.5 mg/5 ml
and 2 mg/5 ml oral liquid and 0.5 mg, 0.75 mg, 1.5 mg, 4 mg oral solid
dosage form.
Section 17.5.1: Addition of 200 ml and 500 ml and 1 L packet sizes for
oral rehydration therapy.
Section 22.1: Addition of misoprostol 200 microgram tablet to the
complementary list with the note that it is for the management of
incomplete abortion and miscarriage.
Section 24.5: Addition of nicotine replacement therapy chewing gum 2 mg
and 4 mg and transdermal patches 5 mg to 30 mg/16 hours and 7 mg to 21
mg/24 hours NRT.
Section 25.1: Addition of beclomethasone 100 microgram per dose
inhalation formulation (aerosol, CFC free form).
3. The Committee recommended that the following medicines should be
deleted from the Model List:
Section 6.2.4: Deletion of the 60 mg + 30 mg combination of rifampicin +
isoniazid and the 60 mg + 30 mg + 150 mg combination of rifampicin +
isoniazid + pyrazinamide on the basis that these combinations provide an
inefficacious dose for children.
Section 6.4.2: Deletion of the 200 mg and 333 mg tablet formulations of
indinavir on the basis that these formulations are not needed as part of
a comprehensive antiretroviral treatment programme.
Section 6.4.2: Deletion of all formulations of nelfinavir on the basis
of non-availability and reduced need for this medicine as part of a
comprehensive antiretroviral treatment programme.
Section 6.4.2: Deletion of the 40 mg tablet formulation of stavudine on
the basis of its safety profile and to ensure consistency with WHO
guidelines.
Section 6.5.2: Deletion of pentamidine powder for injection 200 mg and
300 mg on the basis that it is no longer recommended for the treatment
visceral leishmaniasis in adults and to provide concordance between the
EML and EMLc.
Section 8.2: Deletion of cisplatin powder for injection 10 mg and 50 mg
in vial as carboplatin is superior.
Section 12.2: Deletion of quinidine 200 mg tablet and procainamide 100
mg/ml injection due to their inferior efficacy and safety compared with
other antiarrhythmic medicines.
Section 17.2: Deletion of promethazine on the grounds of its lack of
efficacy in post operative nausea and vomiting.
4. The Committee considered proposals for the following medicines but
rejected their inclusion in the Model List:
Section 4.2: Pralidoxime injection - rejected on the grounds that the
current available evidence from studies in adults did not sufficiently
demonstrate its efficacy and safety.
Section 5:
Lamotrigine tablets and chewable dispersible tablets - rejected on the
grounds of insufficient evidence of its superior safety, efficacy and
cost-effectiveness compared to comparators and the availability of
suitable alternative antiepileptics which are already on the Model List.
Midazolam oral liquid - rejected on the grounds of insufficient evidence
to show its effectiveness and safety in community settings for seizures
and the availability of a suitable alternative already on the Model
List.
Section 6.4.2.1: Zidovudine + lamivudine + abacavir fixed-dose
combination tablet - rejected on the grounds of a lack of specific
evidence of the superior efficacy of this fixed dose combination and
where the combination is required in individual cases, it can be
achieved with the medicines already listed.
Section 6.4.3: Amantadine and rimantadine tablets, capsules and oral
liquid formulations, oseltamivir capsules and oral suspension, zanamivir
powder for oral inhalation - rejected on the grounds that the evidence
to support the effectiveness of any of the four antivirals for treatment
of avian flu is of a very low quality.
Section 7: Sumatriptan 50 mg tablet - rejected on the grounds that the
comparative efficacy, safety and cost effectiveness of Sumatriptan
versus other triptans and aspirin was not established.
Section 10: Tranexamic acid intravenous infusion - rejected on the
grounds that there is not enough evidence of its effectiveness in
indications that are relevant to public health priorities at this time.
Section 17: Endar syrup - the application was rejected on the grounds
that it was incomplete. It did not include any scientific evidence for
the efficacy and safety of the proposed product and did not define the
product composition in a way that is reproducible.
Section 22.1: Misoprostol 200 micrograms tablet, for the prevention of
post-partum haemorrhage - the application was rejected on the grounds
that the evidence available to the Committee at the present time did not
establish the comparative effectiveness and safety in the proposed
context and setting for use of the product.
Section 24.1: Clozapine, olanzipine, risperidone, quetiapine,
aripiprazole and zipasidone - rejected on the grounds that the
application did not provide sufficient information regarding the
comparative effectiveness and safety of the proposed medicines.
Committee requested a formal review of this section for consideration at
the next meeting.
Section 24.2.1: Paroxetine and sertraline - rejected on the grounds of
insufficient evidence of their comparative effectiveness, safety and
cost-effectiveness at this time.
Section 24.3: Escitalopram 5 mg tablet, paroxetine 20 mg tablet,
sertraline 50 mg tablet - rejected on the grounds that the evidence did
not support the public health need or comparative effectiveness, safety
and cost-effectiveness for their addition at this time.
Section 25: Cromoglicic acid - re-instatement was rejected on the
grounds that there was no new supporting evidence to show its superior
safety and efficacy for the treatment of asthma at this time.