[e-farmacos] OMS: Farmacovigilancia de antirretroviralesen paises de bajos recursos

["Canas, Martin" <macanas@netverk.com.ar>]

Estimadas y estimados,

Un documento de la OMS que puede ser de utilidad:

Pharmacovigilance for antiretrovirals in resource-poor countries 
[pdf 391kb] 

Introduction 

There is considerable experience in the developed world with the use of antiretroviral medicines (ARVs). They are associated with significant safety concerns including serious adverse reactions to medicines (ADRs), with both short- and long-term effects. The outcome of these long-term adverse effects is unknown. The reactions include altered body fat distribution (lipodystrophy), hypersensitivity reactions, hepatic disorders, acute pancreatitis, muscle damage (myopathy) of the newborn and lactic acidosis. These and other reactions may damage confidence in any national ARV programme and affect patient adherence. With the erosion of confidence in the safety of medicines and of the programme, patients may stop taking these life-prolonging medicines leading to problems for themselves and for society as a whole. Poor adherence is known to lead to failure of therapy in the patient (he or she will not get well and may die) and development of resistance by the virus leading to reduced efficacy of these life-prolonging medicines. 

Little is known about the toxicity profile of ARVs in developing countries. These countries have special factors and conditions that are very different from those of the developed world and medicine use and safety may therefore vary considerably. The relevant factors and conditions include the existence of comorbid conditions such as tuberculosis (TB), malaria and other infections; malnutrition; heavy reliance on traditional and/or alternative therapies; insufficient numbers of trained doctors and pharmacists; abuse of prescription-only medicines; and likelihood of medicine interactions. In addition, the local systems for the delivery of health care will rely on people who may not have the necessary training, knowledge or expertise, and medicine regulatory systems are either nonexistent or are not adequately equipped to deal with medicine safety issues. 

The monitoring of ARVs in these populations is therefore of paramount importance, and methods of monitoring are the subject of this article. This document should be considered in conjunction with a detailed assessment of the WHO publication, The safety of medicines in public health programmes: pharmacovigilance an essential tool, which includes much information that is not repeated here. 

Disponible en:
http://www.who.int/entity/medicines/publications/PhV_for_antiretrovirals.pdf

Saludos,

Martin

Martin Canas
GAPURMED
La Plata 
(Argentina)
macanas@netverk.com.ar