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Targeted Spontaneous Reporting: Assessing Opportunities to Conduct Routine Pharmacovigilance for Antiretroviral Treatment on an International Scale.

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Rachlis B, Karwa R, Chema C, Pastakia S, Olsson S, Wools-Kaloustian K, Jakait B, Maina M, Yotebieng M, Kumarasamy N, Freeman A, de Rekeneire N, Duda SN, Davies MA, Braitstein P,


Rachlis B, Karwa R, Chema C, Pastakia S, Olsson S, Wools-Kaloustian K, Jakait B, Maina M, Yotebieng M, Kumarasamy N, Freeman A, de Rekeneire N, Duda SN, Davies MA, Braitstein P, (click to view)

Rachlis B, Karwa R, Chema C, Pastakia S, Olsson S, Wools-Kaloustian K, Jakait B, Maina M, Yotebieng M, Kumarasamy N, Freeman A, de Rekeneire N, Duda SN, Davies MA, Braitstein P,

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Drug safety 2016 6 9()

Abstract
INTRODUCTION
Targeted spontaneous reporting (TSR) is a pharmacovigilance method that can enhance reporting of adverse drug reactions related to antiretroviral therapy (ART). Minimal data exist on the needs or capacity of facilities to conduct TSR.

OBJECTIVES
Using data from the International epidemiologic Databases to Evaluate AIDS (IeDEA) Consortium, the present study had two objectives: (1) to develop a list of facility characteristics that could constitute key assets in the conduct of TSR; (2) to use this list as a starting point to describe the existing capacity of IeDEA-participating facilities to conduct pharmacovigilance through TSR.

METHODS
We generated our facility characteristics list using an iterative approach, through a review of relevant World Health Organization (WHO) and Uppsala Monitoring Centre documents focused on pharmacovigilance activities related to HIV and ART and consultation with expert stakeholders. IeDEA facility data were drawn from a 2009/2010 IeDEA site assessment that included reported characteristics of adult and pediatric HIV care programs, including outreach, staffing, laboratory capacity, adverse event monitoring, and non-HIV care.

RESULTS
A total of 137 facilities were included: East Africa (43); Asia-Pacific (28); West Africa (21); Southern Africa (19); Central Africa (12); Caribbean, Central, and South America (7); and North America (7). Key facility characteristics were grouped as follows: outcome ascertainment and follow-up; laboratory monitoring; documentation-sources and management of data; and human resources. Facility characteristics ranged by facility and region. The majority of facilities reported that patients were assigned a unique identification number (n = 114; 83.2 %) and most sites recorded adverse drug reactions (n = 101; 73.7 %), while 82 facilities (59.9 %) reported having an electronic database on site.

CONCLUSION
We found minimal information is available about facility characteristics that may contribute to pharmacovigilance activities. Our findings, therefore, are a first step that can potentially assist implementers and facility staff to identify opportunities and leverage their existing capacities to incorporate TSR into their routine clinical programs.

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