[e-drug] Drug formulations suitable for use in children (cont'd)

[David Woods <david.woods@stonebow.otago.ac.nz>]

E-drug: Drug formulations suitable for use in children (cont'd)
---------------------------------------------

Dear Atieno,

Yes I agree this is a big problem. I recently presented a poster on this
at ICIUM in Thailand (See text of abstract below).
I now have more data and I am in the process of writing this up for
publication.
I am also putting the database on a web site so it can be accessed free of
charge. I hope that feedback from practitioners in developing countries
will help me to make it relevant and useful to all.
See http://pharminfotech.co.nz/manual/Formulation/oral.htm

Qualitatively we can say that these practices are widespread including
compounding of digoxin liquid, antimalarials, rifampicin, antibiotics and
many others. Safety and efficacy are real issues and these practices may
seriously compromise patient care and outcomes. This is difficult to
quantify but the enquiries I get can't be ignored.
Problems are of course exacerbated by access, cost and registration
processes.
The other issue is education of practitioners on alternatives to
compounding such as tablet dispersion etc.

I am very keen to work with anyone to develop some useful guidelines that
could be circulated to help resolve some of these problems.

Regards,

David Woods
Consultant Pharmacist
University of Otago
Dunedin
NEW ZEALAND
  David Woods <david.woods@stonebow.otago.ac.nz>

Access to Pediatric Formulations in Developing Countries
Woods, D. J.1

1PharmInfoTech Ltd. (NZ), School of Pharmacy, University of Otago,
Dunedin, New Zealand

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.

Objective
This study was designed to gather some preliminary data and to suggest
strategies for improvement.

Method
In the first stage in April 2000, a CD-ROM database was developed with a
companion Web site. To date, the CD has been distributed to more than 40
countries. The database is sent free of charge to developing countries.
Each CD was accompanied by a letter inviting comments and information
requests. Specifically, pharmacists were invited to request information
about formulations not included in the database, and to comment on
problems specific to their country of practice. A Web page for updates to
the database was revised regularly. In the second stage (in progress),
specific developing countries are being targeted for more detailed
analysis of problems and practices.

Results
Data for the first stage of the study were collated for the period April
2001 through March 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.

Examples of problems include:

1. Compounding of antiretroviral liquids from tablets is a common
practice, even though data on stability are lacking.
2. Many practitioners in developing countries have to 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.
3.  Availability of pediatric formulations in developing countries may be
hindered by drug company policy and registration processes.

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 liaison between drug companies and regulatory authorities.

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