Qualidade de medicamentosd infantis

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GLOBAL HEALTH COMMENTARY Review of the Quality of Pediatric Medications in Developing Countries
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Neglected Global Diseases Initiative, University of British Columbia, Vancouver, British Columbia V6T 1Z3, Canada

Department of Clinical Pharmacy, WHO Collaborating Center on Pharmaceutical Research and Science Policy,University of California, San Francisco, San Francisco, California 94118, USA
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Department of Essential Medicines and Health Products (EMP), World Health Organization, Geneva 27, Switzerland Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, British Columbia V6T 1Z3, Canada

Received 6 December 2012; revised 15 January 2013; accepted 18 January 2013 Published online inWiley Online Library (wileyonlinelibrary.com). DOI 10.1002/jps.23474 ABSTRACT: The quality of essential medicines for pediatric populations in developing countries is largely unknown. This review examines quality studies (2000–2011) of medicines on the WHO Essential Medicine List for Children, the quality of a subset of pediatric formulations, and the association of these poor quality medicineswith adverse clinical outcomes. We searched Embase, Medline, BIOSIS, and IPA using MeSH subject terms for quality measures, medicine formulations, and substandard medicines and combined these with 267 medicines, and 91 low-income and lower-middle-income countries. Seventy articles met our inclusion criteria examining the quality of 75 medicines from 28 countries. Content and dissolution tests wereutilized most often. Results indicate that antibacterials, antifungals, and antiretrovirals were consistently of good quality. Quality tests on pediatric formulations were performed on 55 of 75 of the medicines studied and followed the general trend of quality results. Three studies were included that examined clinical consequences of substandard medicines—two cases of diethylene glycol poisoningand one case of substandard malaria drugs. We conclude that there is a need for more quality studies of pediatric formulations of essential medicines in developing countries and their clinical consequences. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci Keywords: drug quality; drug effects; drug interactions; drug resistance; formulation; LMIC; global healthBACKGROUND
The World Health Organization’s (WHO) Model List of Essential Medicines for Children (EMLC) was published in its latest version on March, 2011.1 The list is intended to guide therapeutic treatment for priority conditions for children up to 12 years of age. There are 207 core and 70 supplementary medicines, including 21 with age and weight restrictions. The explanatory notes on page 1 ofthe EMLC state “an entry on the Essential Medicines List carries no assurance as to pharmaceutical quality”; therefore, the
Additional Supporting Information may be found in the online version of this article.Supporting Information Correspondence to: Kishor M. Wasan (Telephone: +604-8224889; Fax: +604-822-3035; E-mail: kishor.wasan@ubc.ca)
Journal of Pharmaceutical Sciences © 2013 WileyPeriodicals, Inc. and the American Pharmacists Association

regulatory agencies within each country are expected to provide pharmacovigilence and an adequate drug surveillance system to protect its residents from substandard and/or counterfeit drugs. Although this is a realistic expectation for high-income countries, lowincome countries (LICs), and lower-middle-income countries (LMICs) may not haveadequate systems;2 pharmacovigilence capacity in Africa has grown to 23 countries by 2010 but most are reported as understaffed and underresourced.3 Within the total distribution of causes of death in 2008 for children under 5 years, HIV/AIDS, diarrhea, malaria, pneumonia, and “other diseases” accounted for 70% of deaths in LICs and 61% of deaths in LMICs.4 All of these conditions can be treated...