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

**URL:** <https://talk.edrugplus.org/t/e-drug-drug-formulations-suitable-for-use-in-children-contd/20070>\
**Category:** e-drug\
**Created:** [July 7, 2004, 12:15am UTC](https://talk.edrugplus.org/t/e-drug-drug-formulations-suitable-for-use-in-children-contd/20070 "2004-07-07T00:15:40Z")\
**Posts on this page:** 1\
**Page:** 1

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**Author:** ![david.woods](https://avatars.discourse-cdn.com/v4/letter/d/67e7ee/32.png) [@david.woods](https://talk.edrugplus.org/u/david.woods)\
**Post date:** [July 7, 2004, 12:15am UTC](https://talk.edrugplus.org/t/e-drug-drug-formulations-suitable-for-use-in-children-contd/20070/1 "2004-07-07T00:15:40Z")

</div>

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](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  
&nbsp;&nbsp;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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