Realities of paediatric pharmacotherapy in the developing world

Abstract

Diseases causing high mortality in children under 5 years of age in resource limited settings (RLS) could be treated if children in these countries had access to existing medicines. It took 30 years before the WHO Essential Medicines List (EML) considered the issue of medicines for children, with the first EML for children being published in 2007. Recent data indicate that less than half of the key paediatric essential medicines are available in countries of sub-Saharan Africa. Problems include substandard medicines, irrational use of medicines, inefficiency and even possible corruption in pharmaceutical management systems. These are global issues which affect RLS most. Clinical trials in developing countries for the benefit of children are needed but challenging in several ways. In this review, the authors will consider the following areas where progress could improve paediatric pharmacotherapy in RLS: registration and regulation of medicines, rational use of medicines, clinical trials in children and restriction of corruption in pharmaceutical management systems.

Better Drug Therapy for the Children of Africa: Current Impediments to Success and Potential Strategies for Improvement

“…Novel and locally applicable knowledge translation and dissemination activities must be identified and put in place, in order to ensure that essential information reaches all the aforementioned in a timely and efficient manner, regardless of geographical, technological, and/or other barriers. Professional organizations can be pivotal in recognizing the importance of disseminating information pertaining to pediatric care, and could help in a significant way to advance these goals [40,41].…”

Medicines for children: Rationale and recent advances

“…Kalle has concluded that, "It is time we adults start to listen to children and accept that flexible solid oral dosage forms are the new paradigm of first choice for developing, procuring, prescribing and demanding medicines for children". Despite this evidence based recommendations, most medicines are given to children in Sri Lanka either as liquid formulations or by manipulating adult dosage forms [32,55]. Both are far from ideal.…”

“…Traditionally, liquid formulations, namely syrups and suspensions, are favored for paediatric oral use. However, many problems are recognized with these formulations, some of which are particularly relevant to RLSs [32,40]. Such problems include (i) expensive manufacturing processes (ii) difficulty in taste masking (iii) logistics of transport and storage (iv) requirement of refrigerator to store the reconstituted suspension (v) requirement of clean water to reconstitute dry powders (vi) the necessity to have more excipients, some of which may be not suitable for children and (vii) poor stability in a tropical climate.…”

“…Children in Sri Lanka continue to receive adult strength fixed solid dosage forms (tablets and capsules) which require manipulation before administration [55]. This may happen in the form of tablet splitting, tablet splitting and dissolving in various liquids tablet crushing and dissolving in various liquids or opening the capsules and administering the powder directly or after mixing with food or drink [32,55]. This is an irrational practice and exposes the child to many risks [43,56,57,58,59].…”

“…In addition, evidence has emerged that results from clinical trials done in RLSs to satisfy the regulatory framework of developed counties (especially the FDA) often do not benefit the children in the RLS in which the trials were largely conducted. In the absence of financial incentives, the pharmaceutical industry generally ignores the children from RLS, who carried the burden to provide the much needed paediatric data, to get marketing approval in developed countries [20,32]. Details of the selection of these essential medicines and all six versions of EMLccan be accessed at http://www.who.int/medicines/publications/essentialmedicines/en/.…”