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Drug Quality &Pharmacovigilence &Treatment Bill Brieger | 27 Oct 2007 03:40 pm

Pharmacovigilence – more than monitoring treatment failure

In August Dodoo et al., reported in The Lancet about community backlash to a deworming program in Ghana. What may have been a few side effects, other diseases or preexisting conditions led to rumors that propelled citizens into ‘mass hysteria and civil unrest,’ and ultimately threatened confidence in the public health system (, vol. 370, August 11, 2007, pp. 445-6).

noguchi-memorial.jpgThis is not Ghana’s first major public relations disaster with medicines. In 2004 Ghana adopted artesunate-amodiaquine as its first line antimalarial drug, which appeared fortuitous since the drug could be manufactured locally. When the amodiaquine component was wrongly formulated in some products and reactions occurred, the public almost rejected the need for ACTs to treat malaria. fortunately pharmacovigilence capacity did exist at the University of Ghana.

Other incidents in vary from ‘exaggerated’ response to side effects as has occurred in the ivermectin distribution programs for controlling onchocerciasis (Semiyaga et al.) to real life threatening reactions during a Pfizer drug trial debacle in Nigeria. Regardless of the ‘real’ pharmacological outcome of public health drug research and distribution programs, community perceptions, responses and rumors must also be monitored and addressed.

Thus, in addition to pharmacological aspects of pharmacovigilence, we also need a social, emotional and cultural barometer in communities where programs are based. According to Dodoo et al., this social vigilance requires, “excellent communication, and crisis management planning to accompany public-health programmes that involve mass administration of a drug.”

Social vigilance can perform two functions. First it can respond quickly to real threats to health and life, whether from drug reactions or use of drugs that are no longer effective. Secondly it can dispel rumors where these threaten the life saving ability of truly safe community drug distribution programs.

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