E-DRUG: First WHO Model EML for Children launched
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[Excellent summary of the launch in London of the new "Make medicines child
size" campaign by Andy Gray of Druginfo. Crossposted with thanks. Pity WHO
didn't change the slogan... WB]
Here's the latest news in the WHO's "Make medicines child size" campaign -
see http://www.who.int/childmedicines/en/index.html.
The 1st WHO Model List of Essential Medicines for Children can be downloaded
from http://www.who.int/entity/childmedicines/publications/EMLc%20(2).pdf
This List was developed by a sub-committee in July 2007, and then endorsed
by the 16th Expert Committee on the Selection and Use of Essential Medicines
in October 2007- their full report can be accessed at
http://www.who.int/entity/childmedicines/publications/WATERMARKED.pdf
The impetus for this work has come from many quarters, but was codified in
the World Health Assembly Resolution WHA60.20: 'Better Medicines for
Children' - see
http://www.who.int/entity/childmedicines/publications/WHA6020.pdf
Here are some materials from the campaign, launched today at Great Ormond
Street Hospital in
London:
"A global need - Launched on 6 December 2007, 'make medicines child size'
is a global campaign spearheaded by WHO to raise awareness and accelerate
action to address the need for improved availability and access to safe
child-specific medicines for all children under 15.
To achieve this goal, more research is needed, more medicines need to be
developed, and improved access measures are essential. At present, many
medicines are not developed for children or available in suitable dosages or
formats; and when they are they are not reaching the children who need them
most. The 'make medicines child size' campaign is an effort to change that
reality. "
The campaign has received endorsements from the following structures and
organisations:
UNITAID - "As paediatric medicines for HIV/AIDS, TB and Malaria are
priorities that we are dealing with … 'make medicines child size' is a major
achievement in the commitment towards ensuring that treatable conditions are
treated, hence reducing suffering, morbidity and mortality at a global
level. We welcome and strongly support this initiative and congratulate WHO
for making it possible for all stakeholders to move in this direction."
Médecins Sans Frontières - "Médecins Sans Frontières welcomes WHO’s ‘make
medicines child size’ initiative, a long overdue move to ensure children’s
access to adapted and affordable essential medicines. The specific needs of
children with regard to essential medicines have long been neglected. MSF
finds it encouraging that WHO is expanding its work on essential medicines
to address the research, development and regulatory gaps that prevent us
from giving good care to children in our programmes around the world."
International Alliance for Better Medicines for Children - "The Alliance for
Better Medicines for Children applauds the release of the first Essential
Medicines List for Children. This is a first step in fulfilling the
commitments from the May 2007 60th World Health Assembly with passage of
“Better Medicines for Children”, [which] is the basis for the current
announcement by the WHO which has enthusiastic support from the Alliance.
The full importance of the resolution cannot be overstated. It signifies the
first substantive global action to recognize the needs of children for
access to appropriate safe, effective, and proven medicines. …The burden of
childhood diseases can be substantively reduced through actions identified
in this resolution. The Alliance looks forward to working with the WHO and
other partner organizations to address all the essential elements of the WHA
Resolution."
World Medical Association - "As we have in the past developed policy on
health care for children in order to improve the care provided to them, we
are now prepared to join WHO‘s effort and actions towards achieving a
healthier future for our children through increased access to quality, safe
and effective child medicines."
International Union of Basic and Clinical Pharmacology (IUPHAR) - "The
IUPHAR (International Union of Basic and Clinical Pharmacology) supports the
World Health Assembly resolution 60.20 and the work required to provide
better medicines for children all over the world."
International Federation of Pharmaceutical Manufacturers & Associations
(IFPMA) - "IFPMA members are supportive of WHO and other initiatives to make
medicines more accessible to children. IFPMA will make this initiative
widely-known among its members and in industry in general…IFPMA members
support and encourage positive, market-based legislative and regulatory
incentive measures, such as the Best Pharmaceuticals for Children Act (BPCA)
in the US and the EU's Community Regulation on medicinal products for
paediatric medicines. So we look forward to working with WHO on sound,
positive initiatives to get existing and future pediatric formulations to
children who need them."
African Medical and Research Foundation (AMREF) - "AMREF is pleased to
support the 'make medicines child size' initiative of WHO. 25% of Africa’s
population are children but for too long they have been denied access to the
medicines they need. AMREF believe that by making medicines child size we
will dramatically increase access to treatment and to better health –
provided that the child size medicines are affordable and easy to
administer."
Global Health Council - "Ensuring the survival of children is at the heart
of the movement for improved global health, and it has taken us far too long
to address the unnecessary risk to their health created by the lack of
appropriate and accessible medicines. The Global Health Council welcomes
the WHO’s new campaign as a timely and important contribution toward
improving child survival and health."
The National Institute of Child Health & Human Development (NICHD) - "The
NICHD enthusiastically supports the global initiative to assure increased
access to high quality, safe, and effective medications for children. We
are proud to play a role in this initiative, primarily through research to
help determine the appropriate dose, safety, and efficacy information for
children. We look forward to this partnership in anticipation of what it
can accomplish."
Here are the targets:
"Challenges and actions
Reducing child mortality and treating children affected by major diseases
are global priorities expressed in the Millennium Development Goals four and
six. In May 2007, the World Health Assembly passed resolution WHA60.20
"Better Medicines for Children" setting goals and calling for action by
Member States and WHO to address the global need for children's medicines.
Children's bodies differ from adults and metabolize medicines differently.
Similar differences exist between children of different ages, weights, and
physical conditions. However, many medicines for priority diseases have only
been developed for and studied in adults, leading to a lack of suitable
treatment for children.
WHO, together with partners, has identified research, development,
regulatory, legislative, and supply gaps that need to be addressed to ensure
that children receive the right medicine in the right dose at the right
time. Throughout the five year campaign WHO, together with partners, will
release new efforts to meet specific targets, raise awareness, and galvanize
stakeholder action.
The priority research gaps: medicines do not exist or safety and efficacy
are not known
* Medicines for second-line treatment of TB (for TB resistant to existing
medicines)
* Medicines for TB/HIV co-infection
* Medicines for neglected diseases including schistosomiasis, filariasis,
and soil transmitted worms
The priority development gaps: medicines, research or knowledge exist but
medicines require development or adaptation
* Four quality assured Fixed Dose Combinations (FDC) for malaria
* Four quality assured FDCs for HIV/AIDS
* Three quality assured FDCs for tuberculosis
* Antibiotics for neonatal infections
The priority access gaps: medicines exist but are not reaching those who
need them
* Pain medication
* Oral Rehydration Salts (ORS) with zinc in all areas with high incidence of
diarrhoeal diseases
* Child specific antibiotics for pneumonia
* Asthma medication
How will WHO do it?
To achieve these targets, WHO is encouraging action from stakeholders in the
areas of research, production, regulatory and legislative changes, capacity
building and funding. The agency is also providing the pharmaceutical
industry with key information on public health needs and advising countries
on issues of quality, safety and efficacy of child-specific medicines and
supply management. WHO is further providing and sharing information on
dosage, structure and treatment guidelines with the involved stakeholders."
Here are "10 Facts on children and medicines":
1. According to UNICEF's latest estimate, approximately 10 million children
under five years are expected to die in 2007. More than half of those deaths
will be caused by diseases which could be treated with safe essential child
specific medicines.
2. An estimated 20% of all deaths in children under-five are due to Acute
Lower Respiratory Infections (ALR), representing the single most important
cause of infant mortality worldwide. Pneumonia alone causes approximately
two million deaths every year which could be prevented with proper access to
child-specific medicines.
3. Although contributing to only 3% of all annual deaths in children
under-five, paediatric HIV is growing into a public health emergency. Every
day, an estimated 1 200 children become infected and only 15% end up
accessing treatment, representing half of the adult coverage rates. In 2007
alone, an estimated 420 000 children under 15 years got infected with HIV
and 330 000 have died of AIDS related illnesses.
4. An estimated one million children die every year due to malaria infection
and 40% of the world's children live in malaria-endemic countries. In
Africa, a child dies of malaria every 30 seconds. Although malaria is a
priority illness and has been the subject of numerous global conferences and
calls to action, the issues of access to and development of child specific
treatment have not been fully addressed.
5. An estimated 1.9 million children under five die each year from diarrhoea
and related complications. This amounts to 18% of all under-five deaths and
means that more than 5 000 children are dying every day as a result of
diarrhoeal diseases which could be treated easily and effectively.
6. About 1.1 million (12%) of the 8.8 million new tuberculosis cases in 2005
occurred in children under 14 years of age.
7. WHO estimates that 330 million children under 15 years of age currently
require chemotherapy to prevent Lymphatic Filariasis in endemic areas (Asia,
Pacific, Africa and South America). Another 125 million children under 15
years of age are presently in need of preventive treatment for
schistosomiasis.
8. As an unsafe alternative to missing paediatric formulations, healthcare
workers and parents often use fractions of adult dosage forms or prepare
makeshift prescriptions of medicines by crushing tablets or dissolving
portions of capsules in water.
9. There is little knowledge about the effects certain medicines can have on
children. This is partly due to the fact that fewer clinical trials are
conducted in children than in adults. According to studies published by WHO
in 2005, potentially harmful medicine errors may be three times more common
in the paediatric population than in adults.
10. According to UNICEF and WHO, an Ethiopian child is 30 times more likely
to die by his or her fifth birthday than a child in Western Europe.
And, lastly, a Q & A:
1- Don't children's medicines already exist?
Yes, however, many essential medicines do not exist in child-size dosage
forms or there may not be enough information about the medicines' efficacy
and safety. Currently, many medicines for priority diseases are not
developed for children; and if they are they are not reaching the children
who need them most.
For children with chronic conditions, such as HIV/AIDS, where several
medicines must be taken daily, the fixed-dose combination approach - several
medicines in one pill - is best. However, the few existing paediatric fixed
dose combinations developed for children are generally three times more
expensive than the adult dosage form.
2- Why is it important?
Approximately 10 million children under five years old are expected to die
in 2007, more than half of these due to illnesses and diseases which could
be treated with safe essential paediatric medicines manufactured to suit the
age, physical condition and body weight of the child taking them.
Children's bodies metabolize medicines differently from adults. Therefore
they need different dosage forms. Similar differences also exist between
children of different ages, body weights and physical conditions.
There is little knowledge about the effects certain medicines can have on
children. Apart from dose, children's medicines need to be in a format that
is palatable to children. Small children have trouble swallowing big tablets
whereas oral solutions or syrups are much easier.
3- Why now?
2007 marks the 30th anniversary of the Model List of Essential Medicines.
Over time, children's medicines have been included in this list but there
has not been a comprehensive review of what children's medicines are
available, what medicines are needed, and what needs to be done to address
the gaps.
Looking to the future, WHO and its partners identified addressing the need
for safe, effective and accessible medicines for children as a priority, as
demonstrated by the World Health Assembly resolution WHA60.20 passed in May
2007.
To ensure greater access to children's medicines, there needs to be work
done across sectors. While many stakeholders are taking individual steps
towards ensuring improved access -- regulatory and legislative bodies are
introducing changes, governments are providing more funds towards these
efforts -- there is an opportunity for global collaboration to really make a
difference.
4- What are the priority medicine areas?
The priority areas are HIV/AIDS, malaria, pneumonia, tuberculosis and
diarrhoea, which are together responsible for over 50% of under-five deaths.
This initiative will aim to ensure that appropriate medicines and
formulations are available and accessible to treat these diseases.
5- What are WHO's specific targets?
Within the next five years and with the help of all stakeholders, the
campaign aims to tackle the priority research gaps relating to medicines for
second-line treatment of TB (for TB resistant to existing medicines);
medicines for TB/HIV co-infection; and medicines for neglected diseases -
schistosomiasis, filariasis, and soil transmitted worms.
The campaign aims to further tackle development gaps related to four quality
assured Fixed Dose Combinations (FDC) for malaria; four FDCs for HIV/AIDS;
three FDCs for tuberculosis; and antibiotics for neonatal infections.
Regarding the access gaps, the campaign plans to address problems related to
pain medication, oral rehydration salts with zinc in all areas with high
incidence of diarrhoeal diseases, child specific antibiotics for pneumonia,
and asthma medication.
6- How will WHO achieve these goals?
WHO will galvanize action from stakeholders (legislation/regulation/policy
from governments, research from academia and private sector, production from
industry, funding from donors); provide industry with key information on
public health needs; advise countries on issues of quality, safety and
efficacy, and supply management, and provide the healthcare community with
information on dosage, structure and treatment guidelines.
Specific examples of action include: working with partners for additional
and independent studies on the development of paediatric medicines and their
efficacy and safety; providing bechild specific medicines to prescribers,
pharmacists and health workers; exploring ways of fast-tracking the
regulation of quality paediatric formulations; establishing systems for
ensuring that health facilities have adequate stocks of essential medicines
and clinical consumables for children.
Where possible, clinical trials in children should be encouraged. In the
absence of clinical trials, WHO and the committed stakeholders intend to
identify safety and efficacy guidelines for which essential medicines may be
used in paediatric formulations, as well as improve infrastructure and
equipment to store liquid paediatric formulations - which are less stable
than solid dosages. In addition, WHO will assist in monitoring the use of
unlicensed, off-label and unsafe medicines for children.
regards
Andy