COMMENTS FROM MSF ON - WHO · MSF uses amphotericin B since 2001 and urges the 19th Expert...

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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

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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

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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.





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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.





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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.





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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.






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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.






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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





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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.





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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.





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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.






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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.





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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







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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.





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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.





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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.






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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.





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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.





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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.





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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.






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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.






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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







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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.






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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





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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.





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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.






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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.





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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.





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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.





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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.





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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 multidrug-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

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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

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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

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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

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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.





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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.





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