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COMMENTS FROM MSF ON: Abacavir/lamivudine fixed-dose combination tablets (60/30 mg FDC). ............................................. 6
Abacavir/lamivudine fixed-dose combination tablets (600/300 mg FDC) .......................................... 8
Amphotericin B to be moved to core list. ........................................................................................... 9
Anaesthetics (Children) ..................................................................................................................... 10
Antiulcer medicines .......................................................................................................................... 11
Antiretrovirals: Formulations to be considered for possible deletion.............................................. 12
Artesunate/mefloquine fixed-dose combination tablets (ASMQ FDCs) ........................................... 13
Atazanavir/ritonavir fixed-dose combination tablets (300/100 mg FDC)......................................... 14
Benznidazole paediatric dosage forms ............................................................................................. 15
Chlorhexidine 4% .............................................................................................................................. 16
Dexamethasone .................................................................................................................................. 3
Efavirenz 200 mg scored tablets ......................................................................................................... 7
Efavirenz/lamivudine/tenofovir disoproxil fumarate fixed-dose combination tablets ................... 17
Flucytosine to be moved to core list. ................................................................................................ 18
Fluoxetine ......................................................................................................................................... 19
Glibenclamide - Comparative Safety and Efficacy of Glibenclamide in the Elderly .......................... 20
Lamivudine/nevirapine/zidovudine dispersible tablets (30/50/60 mg FDC) .................................... 21
Lamivudine/stavudine dispersible tablets (30/6 mg FDC) ................................................................ 22
Lamivudine/tenofovir disoproxil fumarate fixed-dose combination tablets (300/300 mg FDC) ..... 23
Lamivudine/zidovudine dispersible tablets (30/60 mg FDC) ............................................................ 24
Misoprostol ......................................................................................................................................... 4
Morphine (new formulation) Children ............................................................................................. 25
Nevirapine 50 mg dispersible tablets ............................................................................................... 27
Nifurtimox in combination with eflornithine (NECT) as a treatment for second stage human African
trypanosomiasis for children in the WHO Model List of Essential Medicines for Children. ............. 26
Palliative care .................................................................................................................................... 28
Palliative care in the WHO Model List of Essential Medicines for adults
and in the WHO Model List of Essential Medicines for children ...................................................... 29
Pegylated interferon ........................................................................................................................... 5
Risperidone ....................................................................................................................................... 30
Second-line antituberculosis medicines (Children) .......................................................................... 31
Spironolactone .................................................................................................................................. 36
Streptomycin to be moved to complementary List .......................................................................... 37
2
3
Dexamethasone
MSF strongly supports dexamethasone to be specifically listed for the indication of
accelerated foetal maturation in anticipated preterm birth in the WHO Model List of Essential
Medicines. Preterm birth complications are the second leading cause of child deaths. The
quality of evidence for dexamethasone to decrease morbidity and mortality (particularly due
to respiratory distresses) in preterm births is high. Dexamethasone has a good tolerance and
safety profile and quality assured generics are worldwide available and affordable. MSF uses
dexamethasone to help pulmonary foetal maturation and urges the 19th
Expert Committee on
the Selection and Use of Essential Medicines to accept this new indication for
dexamethasone.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
4
Misoprostol
MSF strongly supports misoprostol to be specifically listed for the management of postpartum
haemorrhage in the WHO Model List of Essential Medicines. Oral misoprostol is a useful alternative
for injectable oxytocic, when they are not available or ineffective. Single dose of 800 µcg misoprostol
administered sublingually is an easy-to-use evidence-based regimen that can be used when
parenteral administration of oxytocic is not feasible. Unlike other prostaglandins, misoprostol is
relatively inexpensive. Unlike oxytocin which requires cold chain and injectable administration
requiring sterile equipment and trained caregiver, misoprostol is heat stable and thus offers easier
conservation, transport and administration, which are particularly important in rural areas and in
settings with inadequate structures, geographic constraints and limited access to high level care. In
2012, WHO and the International Federation of Gynaecology and Obstetrics (FIGO), updated their
guidelines to recommend the use of misoprostol for prevention and treatment of postpartum
haemorrhage when intravenous oxytocin is unavailable or ineffective. Misoprostol is already listed in
the WHO Model List of Essential Medicines for early medical abortion (with mifepristone),
prevention of postpartum haemorrhage, management of incomplete abortion/miscarriage and
induction of labour and MSF urges the 19th
Expert Committee on the Selection and Use of Essential
Medicines to accept listing also misoprostol for treatment of postpartum haemorrhage.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
5
Pegylated interferon
MSF supports the inclusion of peginterferon alfa-2a and peginterferon alfa-2b in the treatment of
hepatitis C. Worldwide, about 150 million people are infected with hepatitis C and 350,000 people
die each year from hepatitis C-related liver disease. Peginterferon alfa-2a or -2b in combination with
ribavirin is the current standard of care for treatment of chronic hepatitis C in adults. Unfortunately,
peginterferons are expensive and not widely available. Biosimilar versions of peginterferon alfa-2a
and peginterferon alfa-2b exist but there is neither international norms to assess their equivalence
nor system for the evaluation of safety and efficacy of biologics, such as the WHO prequalification of
medicines programme. Availability and affordability of quality assured peginterferon alfa-2a and
peginterferon alfa-2b could be increased if international agreed norms and an international
programme such as WHO prequalification of medicines can be set up for biosimilar products.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
6
Abacavir/lamivudine fixed-dose combination tablets (60/30 mg FDC).
MSF strongly supports the inclusion of the combination abacavir / lamivudine dispersible tablets
(60/30 mg) in the WHO Model Lists of Essential Medicines for children. This FDC is useful in patients
suffering from adverse-effects of tenofovir or zidovudine. MSF urges the 19th
Expert Committee on
the Selection and Use of Essential Medicines to include this combination in the WHO Model List of
Essential Medicines for children; despite the fact that we could not access the application.
MSF is treating 220 000 patients with antiretrovirals in 23 countries.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
7
Efavirenz 200 mg scored tablets
MSF strongly supports the inclusion of the new formulation of efavirenz 200 mg scored tablets,
splittable in 100 mg doses in the WHO Model Lists of Essential Medicines for children. This new
formulation is cost-effective and dose adjustments are easier than with other formulations, due to
the scored tablet easy to split in two 100 mg-doses.
MSF would also like to draw the attention of the Expert Committee to the fact that efavirenz 100 mg
dispersible tablet exists already and is prequalified by WHO prequalification program.
MSF urges the 19th
Expert Committee on the Selection and Use of Essential Medicines to include this
new formulation in the WHO Model List of Essential Medicines for children.
MSF is treating 220 000 patients with antiretrovirals in 23 countries.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
8
Abacavir/lamivudine fixed-dose combination tablets (600/300 mg FDC)
MSF strongly supports the inclusion of the combination abacavir / lamivudine tablets
(600/300 mg) in the WHO Model Lists of Essential Medicines for adults. This FDC is useful
in patients suffering from adverse-effects of tenofovir or zidovudine and WHO 2010
guidelines recommend it as an alternate NRTI for use in first-line, second-line, or triple-
nucleoside regimens. The once-daily tablet intake increases ease of administration and
therefore adherence to treatment. MSF urges the 19
th Expert Committee on the Selection and Use of Essential Medicines to include this
combination in the WHO Model List of Essential Medicines for adults.
MSF is treating 220 000 patients with antiretrovirals in 23 countries.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
9
Amphotericin B to be moved to core list.
MSF agrees with the proposal to moved amphotericin B from the complementary to the core WHO
Model Lists of Essential Medicines (Adults and Children). Amphotericin B is more effective for the
treatment of cryptococcal meningitis in adults and children than other anti-fungal medicines.
MSF uses amphotericin B since 2001 and urges the 19th
Expert Committee on the Selection and Use
of Essential Medicines to move amphotericin B from the complementary to the core WHO Model
Lists of Essential Medicines for adults and for children.
MSF would also like to draw the attention of the Expert Committee to the fact that those products
should reach internationally agreed quality standards as those followed by the WHO prequalification
programs
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
10
Anaesthetics (Children)
MSF endorses the conclusions of the application submitted concerning safe anaesthesia for
neonates (updating section 1 on the WHO Model List of Essential Medicines for children). MSF would draw attention of the Committee that some of these drugs don’t exist in formulations
that allow accurate or easy paediatric dosing and administration, and recommends the development
of paediatric formulations in order to improve safety while administration.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
11
Antiulcer medicines
MSF strongly supports the inclusion of intravenous omeprazole (with a square box, as a
representative of proton-pump inhibitors) in the WHO Model Lists of Essential Medicines. Injectable
proton-pump inhibitors are required as gastric antisecretory treatment, especially in patients with
acute bleeding from a peptic ulcer, or in patients unable to take oral medicines (patients with an
obstruction of the oro-pharynx or the upper gastro-intestinal tract).
MSF uses injectable omeprazole since 2003 and urges the 19th
Expert Committee on the Selection
and Use of Essential Medicines to include injectable omeprazole as a representative of proton-pump
inhibitors in the WHO Model Lists of Essential Medicines.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
12
Antiretrovirals: Formulations to be considered for possible deletion
MSF agrees with the proposal to delete these antiretrovirals from WHO Model Lists of Essential
Medicines (Adults and Children) except for stavudine/lamivudine/nevirapine 12/60/100mg tablets
(d4T/3TC/NVP 12/60/100mg FDC tablets) that should be kept in WHO Model Lists of Essential
Medicines. This dosage formulation is still used in many countries and is also necessary in case of
zidovudine-induced anaemia when abacavir/lamivudine is not available. Therefore MSF urges the
19th
Expert Committee on the Selection and Use of Essential Medicines to delete all antiretrovirals
listed in the application except stavudine/lamivudine/nevirapine 12/60/100mg tablets.
MSF is treating 220 000 patients with antiretrovirals in 23 countries.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
13
Artesunate/mefloquine fixed-dose combination tablets (ASMQ FDCs)
MSF strongly supports the inclusion of the combination artesunate/mefloquine tablets (25 / 55 mg
and 100 / 220 mg) in the WHO Model Lists of Essential Medicines (Adults and Children). These FDCs
present benefit for the treatment of uncomplicated P.falciparum malaria in terms of: ease of
administration (age-based unit dose packaging appropriate for all age groups), adherence to
treatment (once-a-day intake over three day, no need to time the doses with food), and lower
treatment costs. FDCs reduce pill-burden and eliminate the possibility of patients taking only one
component of the combination. The FDCs greatly contribute to decrease the risk of resistance
development.
Finally, the paediatric dosage (25 mg/55mg) can also be used for small children because tablets can
be easily dissolved in water before administration (disintegration in water within 3 minutes). ASMQ
FDC is prequalified by WHO since September 2012 and has therefore been introduced by MSF into
its medicines list.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
14
Atazanavir/ritonavir fixed-dose combination tablets (300/100 mg FDC)
MSF strongly supports the inclusion of the combination atazanavir / ritonavir tablets
(300/100 mg) in the WHO Model Lists of Essential Medicines for adults. This FDC is the
one of the two WHO recommended protease inhibitors for use in second-line regimens, due
to its safety and efficacy profile. The once-daily tablet intake increases ease of administration and therefore adherence to treatment.
MSF urges the 19th
Expert Committee on the Selection and Use of Essential Medicines to include this
combination in the WHO Model List of Essential Medicines for adults.
MSF is treating 220 000 patients with antiretrovirals in 23 countries.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
15
Benznidazole paediatric dosage forms
MSF strongly supports the inclusion of benznidazole 12.5 mg dispersible tablet, for treatment
of Chagas disease (American trypanosomiasis), in the WHO Model List of Essential
Medicines for Children . MSF supports the DNDi application for inclusion of this paediatric
dosage form and also propose to include another dosage form, 50 mg scorable and dispersible
tablet, in order to have all dosage forms appropriate for all age groups. For congenital Chagas
disease, the cure rate is over 90% when administered in the first year after birth and the only
present dosage form, 100 mg adult tablets is not safely usable in neonates and young
children. Doses for benznidazole are respectively from 5-7mg/kg/day and up to 10mg/kg/day
for infants and infants/neonates by 1 year old, and duration of treatment is not less than 30
days and could be up to 60 days. Until paediatric dosage forms exist, health providers had to
use 100 mg tablets, splited, crushed and diluted in drinks before administration. This practice
doest not permit accuracy and safety of administration in neonates and children. In 2011,
WHO supports the need of a dosage form of 12.5mg of benznidazole to facilitate the
preparation of paediatric suspension. MSF urges the 19th
Expert Committee on the Selection
and Use of Essential Medicines to include the two paediatric dosage forms, 12.5 and 50 mg
dispersible tablets, in the WHO Model List of Essential Medicines for Children.
MSF would also like to draw the attention of the Expert Committee to the fact that those
products should reach internationally agreed quality standard as those followed by the WHO
prequalification programs.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
16
Chlorhexidine 4%
MSF strongly supports the inclusion of 7.1% chlorhexidine digluconate solution or gel, delivering 4%
chlorhexidine for umbilical cord care, in the WHO Model List of Essential Medicines for children.
Currently, the WHO Model List of Essential Medicines for children includes two chlorhexidine
solutions: 5% (digluconate) and 20% (digluconate) (needs to be diluted prior to use for cord care).
Randomised controlled trials showed a significant reduction in neonatal mortality after use of a 4%
chlorhexidine solution (7.1% chlorhexidine gluconate) for umbilical cord care. It is important to note
that 5% chlorhexidine digluconate delivers only approximately 2.8% chlorhexidine, a lower level than
what was used in these trials. The very first application for inclusion was made in 2009 but at the
time of revision of the WHO Model List of Essential Medicines in 2009 and in 2011, 7.1%
chlorhexidine digluconate delivering 4% chlorhexidine was not yet commercialised. As this dosage
form is now available and affordable, it has been introduced in January 2013 in MSF medicines list.
MSF urges the 19th
Expert Committee on the Selection and Use of Essential Medicines to include it in
the WHO Model List of Essential Medicines for children.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
17
Efavirenz/lamivudine/tenofovir disoproxil fumarate fixed-dose
combination tablets (600/300/300 mg FDC)
MSF strongly supports the inclusion of the combination efavirenz / lamivudine / tenofovir
disoproxil fumarate tablets (600/300/300 mg) in the WHO Model Lists of Essential
Medicines for adults; despite the fact that we could not access the application.
MSF is treating 220 000 patients with antiretrovirals in 23 countries.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
18
Flucytosine to be moved to core list.
MSF agrees with the proposal to moved flucytosine from the complementary to the core
WHO Model Lists of Essential Medicines (Adults and Children). Flucytosine is effective in
combination with either Amphotericin B or Fluconazole for induction of Cryptococcus
meningitis treatment and WHO Rapid Advice on diagnosis, prevention and management of
cryptococcal disease in HIV-infected adults, adolescents and children recommends
flucytosine in conjunction with Amphotericin B as first line induction therapy for
cryptococcal meningitis. In resource-limited settings, where intravenous amphotericin B
therapy is not available or not possible to administer, flucytosine can be safely and effectively
administered with high-dose fluconazole. Flucytosine is used by MSF in its programs, therefore MSF urges the 19
th Expert Committee on the
Selection and Use of Essential Medicines to move flucytosine from the complementary to the core
WHO Model Lists of Essential Medicines for adults and for children.
MSF would also like to draw the attention of the Expert Committee to the fact that those
products should reach internationally agreed quality standards as those followed by the WHO
prequalification programs.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
19
Fluoxetine (age restriction in the WHO Model List of Essential Medicines for
adults and deletion from the WHO Model List of Essential Medicines for
children)
MSF strongly supports the increase of the age limit from 8 years to 12 years for fluoxetine
and its deletion from the WHO Model List of Essential Medicines for children. MSF uses
fluoxetine to treat depression in adults since 2002 but we do not use fluoxetine in children
below 15 years.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
20
Glibenclamide - Comparative Safety and Efficacy of Glibenclamide in the
Elderly
MSF strongly supports to retain glibencamide in the WHO Model List of Essential Medicines. MSF
uses glibenclamide since 1988 and strongly supports this medicine to retain on the WHO Model List
of Essential Medicines for patients with age restriction (contra-indication in elderly patients). MSF
supports also the inclusion of another second generation sulfonylureas (such as glicazide, with a
square box) to be an alternative to glibenclamide.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
21
Lamivudine/nevirapine/zidovudine dispersible tablets (30/50/60 mg FDC)
MSF strongly supports the inclusion of the combination Lamivudine / nevirapine / zidovudine
dispersible tablets (30/50/60 mg) in the WHO Model Lists of Essential Medicines for children.
The dispersible tablets are easily dispersible in small amount of water before administration, and can
be dispersed in breast milk in order to be administered in neonates and infants. Health professional
and parents can use dispersible tablets more easily than oral liquid formulations. Costs to produce
and to transport dispersible formulations are less than for oral liquid formulations, therefore they
are more affordable.
MSF is treating 220 000 patients with antiretrovirals in 23 countries.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
22
Lamivudine/stavudine dispersible tablets (30/6 mg FDC)
MSF strongly supports the inclusion of the combination lamivudine / stavudine dispersible tablets
(30/6 mg) in the WHO Model Lists of Essential Medicines for children.
The dispersible tablets are easily dispersible in small amount of water before administration, and can
be dispersed in breast milk in order to be administered in neonates and infants. Health professional
and parents can use dispersible tablets more easily than oral liquid formulations. Costs to produce
and to transport dispersible formulations are less than for oral liquid formulations, therefore they
are more affordable.
MSF is treating 220 000 patients with antiretrovirals in 23 countries.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
23
Lamivudine/tenofovir disoproxil fumarate fixed-dose combination tablets
(300/300 mg FDC)
MSF strongly supports the inclusion of the combination lamivudine / tenofovir disoproxil
fumarate tablets (300/300 mg) in the WHO Model Lists of Essential Medicines for adults.
WHO 2010 guidelines recommend this combination as one of the preferred NRTI first-line
regimens for adults in resource-limited settings. This FDC is also a useful alternative, in
combination with nevirapine, in the event of psychiatric adverse-effects of efavirenz. The
once-daily tablet intake increases ease of administration and therefore adherence to treatment. MSF urges the 19
th Expert Committee on the Selection and Use of Essential Medicines to include this
combination in the WHO Model List of Essential Medicines for adults.
MSF is treating 220 000 patients with antiretrovirals in 23 countries.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
24
Lamivudine/zidovudine dispersible tablets (30/60 mg FDC)
MSF strongly supports the inclusion of the combination lamivudine / zidovudine dispersible tablets
(30/60 mg) in the WHO Model Lists of Essential Medicines for children. The dispersible tablets are
easily dispersible in small amount of water before administration, and can be dispersed in breast
milk in order to be administered in neonates and infants. Health professional and parents can use
dispersible tablets more easily than oral liquid formulations. Costs to produce and to transport
dispersible formulations are less than for oral liquid formulations, therefore they are more
affordable.
MSF is treating 220 000 patients with antiretrovirals in 23 countries.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
25
Morphine (new formulation) Children
MSF strongly supports the inclusion of morphine slow-release granules and tablets in the WHO
Model List of Essential Medicines for children. Morphine is the strong opioid of first choice to treat
moderate and severe pain. Access to appropriate formulations and dosage forms of morphine is
essential for the treatment of moderate to severe acute and persisting pain in children. For the
treatment of moderate to severe pain, oral morphine is an effective medication. Immediate-release
morphine must be given 6 times per day. With twice-a-day intake slow release morphine regimens
can provide better quality of life and improve patient adherence to analgesic treatment. For the
treatment of moderate to severe persisting pain including cancer pain, in adults and children, MSF
has recommended the use of morphine slow release formulations since 2002.
MSF urges the 19th Expert Committee on the Selection and Use of Essential Medicines to include the
formulations of morphine modified release in the WHO Model List of Essential Medicines for
children
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
26
Nifurtimox in combination with eflornithine (NECT) as a treatment for
second stage human African trypanosomiasis for children in the WHO
Model List of Essential Medicines for Children.
Since January 2010, MSF has used NECT as first line treatment for second stage human African
trypanosomiasis and over 1500 patients, including children, have been treated. NECT has proved to
be highly effective and safe, and furthermore children have presented fewer adverse effects,
including fatalities, than adults.
This very good tolerance has also been reported by the WHO and the DNDi. NECT shows improved
practicability (2 versus 4 daily infusions) and shorter duration of treatment (7 versus 14 days) than
eflornithine single-therapy. NECT prevents the selection of resistant parasite strains and therefore
preserves the few drugs existing to treat second stage human African trypanosomiasis. In the
present WHO Model List of Essential Medicines for children, are included only eflornithine as
single-therapy and, in complementary list, melarsoprol (which high toxicity directly leads to the
death of 3 to 5% of patients).
MSF urges the 19th
Expert Committee on the Selection and Use of Essential Medicines to include the
nifurtimox to be used in combination with eflornithine in the WHO Model List of Essential
Medicines for children.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
27
Nevirapine 50 mg dispersible tablets
MSF strongly supports the inclusion of nevirapine 50 mg dispersible tablets in the WHO Model Lists
of Essential Medicines for children. The dispersible tablets are easily dispersible in small amount of
water before administration, and can be dispersed in breast milk in order to be administered in
neonates and infants. Health professional and parents can use dispersible tablets more easily than
oral liquid formulations. Costs to produce and to transport dispersible formulations are less than for
oral liquid formulations, therefore they are more affordable.
MSF is treating 220 000 patients with antiretrovirals in 23 countries.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
28
Palliative care
MSF strongly supports the application prepared by the International Association for Hospice and
Palliative Care (IAHPC). MSF uses for several years most of the medicines mentioned in the
application (except docusate sodium, lorazepam, senna and sodium picosulfate) and urges the 19th
Expert Committee on the Selection and Use of Essential Medicines to include all the recommended
medicines and formulations needed for palliative care.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
29
Palliative care in the WHO Model List of Essential Medicines for adults and
in the WHO Model List of Essential Medicines for children
MSF strongly supports the needs to give higher visibility to Medicines for palliative care. These
medicines are currently included in the WHO Model List of Essential Medicines Subsection 8.4 in
Section 8, together with Antineoplastic and Immunosuppressive. At this time, palliative care does
not exist in many countries or is not well integrated in the health care system. The Model List of
Essential Medicines is an essential document for countries in developing their national lists of
essential medicines and national guidelines. Highlighting these medicines for palliative care will
support best clinical practices in palliative care and will promote appropriate availability and
accessibility of palliative care medicines.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
30
Risperidone
MSF strongly supports the inclusion of risperidone in the WHO Model List of Essential Medicines, for
psychotic disorders including schizophrenia, schizoaffective disorder, mania with psychosis, and
depression with psychosis. Risperidone is an atypical antipsychotic widely used for the two past
decades (FDA approval in 1993). Risperidone presents comparable efficacy as typical antipsychotics
already listed in WHO Model List of Essential Medicines (chlorpromazine, fluphenazine, haloperidol)
and a more tolerable side effect and safety profile. Risperidone is registered worldwide and went
off-patent in 2003, so many quality assured generic forms are available and affordable. Risperidone
is the atypical antipsychotic used in MSF programs since 2009.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
31
Second-line antituberculosis medicines (Children)
MSF strongly supports the inclusion of all second-line antituberculosis medicines listed in the review,
in the WHO Model List of Essential Medicines for children. MSF would also like to draw the attention
of the Expert Committee to the fact that capreomycin should be used when resistance to an
aminoside is suspected, not only in case of XDR, and that linezolid and clofazimine should be added
on both WHO Model Lists of Essential Medicines for children and for adults. There are limited data
on the use of terizidone. MSF would also like to draw the attention of the Expert Committee to the
fact that few second-line antituberculosis medicines exist in child-friendly formulations. Paediatric
formulations for easy dosing and administration are urgent to develop. Those medicines should
reach internationally agreed quality standards and should be WHO prequalified.
Please find below some additional references.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
32
References for linezolid:
Condos R, Hadgiangelis N, Leibert E, Jacquette G, Harkin T, Rom WN. Case series report of a linezolid-
containing regimen for extensively drug-resistant tuberculosis. Chest 2008; 134:187-92.
Fortun J, Martin-Davila P, Navas E, et al. Linezolid for the treatment of multidrug-resistant
tuberculosis. J Antimicrob Chemother 2005; 56:180-5.
Park IN, Hong SB, Oh YM, et al. Efficacy and tolerability of daily-half dose linezolid in patients with
intractable multidrug-resistant tuberculosis. J Antimicrob Chemother 2006;58:701-4.
Park IN, Hong SB, Oh YM, et al. Efficacy and tolerability of daily-half dose linezolid in patients with
intractable multi- drug-resistant tuberculosis. J Antimicrob Chemother 2006; 58:701-4.
Schecter GF, Scott C, True L, Raftery A, Flood J, Mase S. Linezolid in the treatment of multidrug-
resistant tuberculosis. Clin Infect Dis 2010; 50:49-55.
G Sotgiu, et al. Efficacy, safety and tolerability of linezolid containing regimens in treating MDR-TB
and XDR-TB: systematic review and meta-analysis. ERJ April 10, 2012
H. Cox, N. Ford: Linezolid for the treatment of complicated drug-resistant tuberculosis: a systematic
review and meta-analysis. Int J Tuberc Lung Dis 2012; 16: 447-454.
Singla R, Caminero JA, Jaiswal A, et al. Linezolid: an effective, safe and cheap drug for patients failing
multidrug-resistant tuberculosis treatment in India. Eur Respir J 2012; 39: 956-962.
Chang KC, Leung CC, Daley CL. Linezolid for multidrug-resistant tuberculosis. Lancet Infect Dis 2012;
12: 502-503.
Lee M, Lee J, Carroll MW, et al. Linezolid for Treatment of Chronic Extensively Drug-Resistant
Tuberculosis. N Engl J Med 2012; 367:1508-18.
References for clofazimine:
1- Used in Switzerland
R. Gimmia, G. E. Pfyffer b, O. Brändlia. Tuberculose multirésistante – guérissable en Suisse. Forum
Med Suisse 2003, 4 : 80-90.
http://www.medicalforum.ch/pdf/pdf_f/2003/2003-04/2003-04-283.PDF
33
2- Used in Netherland
Van Ingen, J., M. J. Boeree, A. Wright, T. van der Laan, P. N. R. Dekhuijzen, and D. van Soolingen.
Second-line drug resistance in multi-drug resistant tuberculosis cases of various origins in the
Netherlands. Int. J. Tuberc. Lung Dis 2008. 12:1295-1299
http://www.ncbi.nlm.nih.gov/pubmed/18926040
3- Used and officially recommended in US
Banerjee R et al. Extensively drug resistant TB : new strains, new challenges. Expert Rev Anti Infect
Therap 2008; 6(5): 713-724.
http://www.cdph.ca.gov/programs/tb/Documents/TBCB-Banerjee et al.Extensively drug-resistant
tb-new strains new challenges.pdf
Drug-Resistant Tuberculosis: A Survival Guide for Clinicians, 2nd edition 2008.
http://www.currytbcenter.ucsf.edu/
http://www.currytbcenter.ucsf.edu/drtb/about.cfm
4- Used in Germany
Stefan H Blaas, Ralf Mütterlein, Johannes Weig, Albert Neher, Bernd Salzberger, Norbert Lehn and
Ludmila Naumann. Extensively drug resistant tuberculosis in a high income country: A report of four
unrelated cases. BMC Infectious Diseases 2008, 8:60 http://www.biomedcentral.com/1471-
2334/8/60
5- Recommended in Australia
Queensland tuberculosis control centre: "Guidelines for treatment of tuberculosis".
http://www.health.qld.gov.au/ph/documents/qtbcc/31042.pdf
6- Used in Peru
Comprehensive Treatment of Extensively Drug-Resistant Tuberculosis. NEJM 2008; 359 (6): 563-574.
http://content.nejm.org/cgi/content/full/359/6/563
34
Eva Nathanson, Catharina Lambregts-van Weezenbeek, Michael L. Rich, Rajesh Gupta et al.
Multidrug-resistant Tuberculosis Management in Resource-limited Settings. Emerging Infectious
Diseases 2006, 12, n°9.
http://wwwnc.cdc.gov/eid/article/12/9/05-1618_article.htm
7- Used in Argentina
Waisman JL, Palmero DJ, Alberti FA, Guemes Gurtubay JL,Francos JL
Multidrug-resistant tuberculosis (MDRTB) AIDS related patients outcome improvement in Buenos
Aires. Argentina. Int Conf AIDS 2000 Jul 9-14; 13
http://ww1.aegis.org/conferences/iac/2000/MoPeB2255.html
8- Used in Turkey
Nuri Ozkutuk et al. Second-Line Drug Susceptibilities of Multidrug-Resistant Mycobacterium
tuberculosis Isolates in Aegean Region – Turkey. Turk J Med Sci 2008; 38 (3): 245-250
http://journals.tubitak.gov.tr/medical/issues/sag-08-38-3/sag-38-3-10-0709-17.pdf
9- Used in Brazil
João Alves de Araújo-Filho; Arioldo Carvalho Vasconcelos-Jr; Eduardo Martins de Sousa; Colombina
da Silveira; Elisangela Ribeiro; André Kipnis; Ana Paula Junqueira-Kipnis. Extensively drug-resistant
tuberculosis: a case report and literature review. Braz J Infect Dis vol.12 no.5 Salvador Oct. 2008
http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1413-86702008000500019
Dalcolmo, Margareth Pretti; Andradre, Mônica Kramer de Noronha and Picon, Pedro Dornelles.
Multiresistant tuberculosis in Brazil: history and control. Rev. Saúde Pública vol.41 suppl.1 São
Paulo Sept. 2007
http://dx.doi.org/10.1590/S0034-89102007000800006
10- Officially recommended in Canada
Canadian tuberculosis standards 6th
edition 2007.
http://www.phac-aspc.gc.ca/tbpc-latb/pubs/pdf/tbstand07_e.pdf
11- Used in Bangladesh
35
Van Deun A, Salim MA, Das AP, Bastian I, Portaels F Results of a standardised regimen for multidrug-
resistant tuberculosis in Bangladesh. Int J Tuberc Lung Dis. 2004 May;8(5):560-7.
http://www.ncbi.nlm.nih.gov/pubmed/15137531
Armand Van Deun, Aung Kya Jai Maug, Md Abdul Hamid Salim, Pankaj Kumar Das, Mihir Ranjan
Sarker, Paul Daru, and Hans L. Rieder. Short, Highly Effective, and Inexpensive Standardized
Treatment of Multidrug-resistant Tuberculosis. Am J Respir Crit Care Med 2010; 182 : 684–692.
http://ajrccm.atsjournals.org/content/182/5/684.full.pdf
36
Spironolactone
MSF strongly supports the application for adding aldosterone antagonists in the WHO Model List of
Essential Medicines, as a therapeutic class of medicines for treatment of patients with heart
failure (Section 12.4 of the current List) and specifying spironolactone as the representative of
this aldosterone antagonist class (with a square box). Spironolactone is an effective, worldwide
available and affordable medicine. MSF uses spironolactone since 1988 for treatment of
patients with heart failure.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland
37
Streptomycin to be moved to complementary List
MSF agrees with the Stop TB Department’s proposal to moved streptomycin from the core
WHO Model Lists of Essential Medicines (Adults and Children) to the complementary lists.
Streptomycin is no more recommended as part of first line treatment in regimens for children
and adults. Streptomycin should be avoided in children because of its adverse-effect profile,
including irreversible ototoxicity. Therefore, MSF urges the 19th Expert Committee on the
Selection and Use of Essential Medicines to move streptomycin from core Model Lists of
Essential Medicines to complementary Model Lists of Essential Medicines.
Myriam Henkens MD,MPH
International Medical Coordinator
Médecins Sans Frontières
International Office
Rue de Lausanne 78
CP 116
1211 Geneva 21
Switzerland