Access to Pediatric Formulations in Developing Countries

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Access to Pediatric Formulations in Developing
Countries

• David J WoodsSchool of Pharmacy, University of
  Otago, Dunedin, New Zealand
• Pharminfotech Consultancydavid.woods_at_stonebow.ot
  ago.ac.nz

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ABSTRACT
Problem Statement Oral liquid preparations for
administration of doses to children are not
freely available in developing countries.
Consequently, pharmacists frequently must modify
solid-dose forms. Information on the stability of
these formulations is often lacking, difficult to
find, inconsistent, or only applicable for use in
a handful of developed countries. Objective To
gather some preliminary data on the availability
of oral liquid preparations and related pharmacy
practices in developing countries, and to suggest
strategies for making improvements. Design
Phase 1 A prospective analysis of pediatric
formulation questions received by email
Phase 2 (still in progress) A survey of
product availability in specific countries or
regions. Setting and Population Phase 1
Pharminfotech Ltd. (NZ) developed an information
database on more than 80 oral liquid
formulations. The database is available on CD-ROM
and on the Web. From April 2001, the CD has been
distributed to more than 40 countries, free of
charge to developing countries. The main
recipients of the CD were hospital pharmacists,
community pharmacists and academic institutions.
Each mailing included a letter inviting comments
on country-specific problems and information
requests. Phase 2 Specific developing countries
are being targeted for a more detailed analysis
of problems and practices. Outcome Measures
Phase 1 The requests for formulation
information on pediatric liquids were collated
and a comparison made between requests received
from developing and developed countries. In
phase 2 more specific information is being
gathered from selected countries to ascertain if
access to pediatric formulations is compromised
and possible reasons for this.. Results Phase 1
Data were collated for the period April
2001March 2003. A total of 269 information
requests were received from 28 countries. The
requests involved more than 30 different drugs.
Important general and country-specific problems
have been identified. Lack of commercial products
and information on extemporaneous formulations
are contributing to suboptimal treatment in many
countries. One problem found was the common
practice of compounding of antiretroviral liquids
from tablets despite the lack of data on
stability many practitioners in developing
countries must compound liquids for treatment of
tuberculosis, malaria, HIV/AIDS, and
cardiovascular disease without guarantee of
effectiveness. Commercially manufactured products
are widely available in developed countries.
Preliminary data from phase 2 suggests that
availability of pediatric formulations in
developing countries may be hindered by high
costs and the reluctance of companies to
register and make products available in
uneconomic markets. Conclusion Many developing
countries have poor access to commercially
manufactured pediatric formulations. Practices
for compounding are inconsistent, and the
problems are exacerbated by lack of ingredients
and information. Strategies to improve the
situation include international guidelines,
increased availability of information,
practitioner education, and improved product
availability.
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Background Oral liquid preparations for the
administration of doses to children are not
freely available. Consequently, pharmacists
frequently have to modify solid dose forms.
Information on the stability of these
formulations is often lacking, difficult to find,
inconsistent, or only applicable for use in a
handful of developed countries. Information on
the situation in developing countries is lacking,
but anecdotally it has been ascertained that the
use of substandard preparations for the treatment
of tuberculosis, HIV/AIDS, and malaria is
widespread.
Objectives To gather some preliminary data on
the availability of oral liquid preparations and
related pharmacy practices in developing
countries, and to suggest strategies for making
improvements.
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Methods 1 Phase 1 A prospective analysis of
pediatric formulation questions received by
email. Pharminfotech Ltd. Developed an
information database on more than 80 oral liquid
formulations. The database is available on CD-ROM
and on the Web. From April 2001, the CD has been
distributed to more than 40 countries, free of
charge to developing countries. Each mailing
included a letter inviting information requests
and comments on country-specific problems.
Pharmacists were invited to request information
about formulations not included in the
database.Enquiries received were categorized
according to country of origin, drug and
therapeutic use. Requests were collated and a
comparison made between requests from developed
and developing countries.
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Methods 2 Phase 2 (still in progress) A
survey of product availability in specific
countries or regions to see if access to
pediatric medicines is compromised. Analysis is
being performed on the possible reasons for
inter-country variations in access to pediatric
formulations.
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Results 1 Phase 1 Data were collated for the
period April 2001 March 2003. A total of 269
information requests were received from 28
countries. These involved more than 30 different
drugs. Requests from developing countries
(Fig.1) frequently involved liquid formulations
for the treatment of infectious disease including
TB, malaria and HIV. There were also requests
involving antibiotic mixtures and cardiovascular
drugs. The majority of these preparations are
commercially available. Requests from developed
countries (Fig.2) tended to involve formulations
not commercially available or more specific
information on the use of bases or preservatives.
There were also requests for information on
specialist formulations for the treatment of
metabolic disease in neonates and the use of
sildenafil (Viagra) for infant pulmonary
hypertension.
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• Results 2Phase 2
• Information has been partially collected from the
  Caribbean, Nepal, Vanuatu and Kenya but most
  country specific surveys are still
  pending.Examples of problems identified are
• Compounding of antiretroviral liquids from
  tablets
• is a common practice, even though data on
  stability are lacking.
• Commercially available liquid formulations are
  often not available in developing countries
• Many practitioners in developing countries have
  to compound liquids for the treatment of malaria,
  TB, cardiovascular disease (e.g. digoxin) without
  guarantee of effectiveness. These preparations
  are freely available in developed countries.
• Availability in developing countries may be
  hindered by high costs and the reluctance of
  companies to make products available in
  uneconomic markets.

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Conclusions

• Many developing countries have poor access to
  commercially manufactured pediatric preparations
• Practices for compounding are inconsistent, and
  the problems are exacerbated by lack of
  ingredients and information
• Strategies to improve the situation include
  international guidelines, increased availability
  of information, practitioner education and
  improved product availability.

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eMixt CD-ROM The complete database is now
available free of charge on the
Internet. http//pharminfotech.co.nz/manual/Formu
lation/oral.htm Further development is planned
in response to requests for information and
feedback.