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



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.



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.



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.



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.
Ontario HIV Treatment Network, Toronto, ON, Canada.
Beth
B
Rachlis
College of Pharmacy, Purdue University, West Lafayette, IN, USA.|Academic Model Providing Access to Healthcare, Eldoret, Kenya.
Rakhi
R
Karwa
Academic Model Providing Access to Healthcare, Eldoret, Kenya.
Celia
C
Chema
College of Pharmacy, Purdue University, West Lafayette, IN, USA.|Academic Model Providing Access to Healthcare, Eldoret, Kenya.
Sonak
S
Pastakia
Uppsala Monitoring Centre, Uppsala, Sweden.
Sten
S
Olsson
Academic Model Providing Access to Healthcare, Eldoret, Kenya.|School of Medicine, Indiana University, Indianapolis, IN, USA.
Kara
K
Wools-Kaloustian
Academic Model Providing Access to Healthcare, Eldoret, Kenya.|Moi Teaching and Referral Hospital, Eldoret, Kenya.
Beatrice
B
Jakait
Academic Model Providing Access to Healthcare, Eldoret, Kenya.|Moi Teaching and Referral Hospital, Eldoret, Kenya.
Mercy
M
Maina
College of Public Health, Ohio State University, Columbus, OH, USA.|Kinshasa School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of Congo.
Marcel
M
Yotebieng
YRGCARE Medical Centre, Chennai Antiviral Research and Treatment Clinical Research Site (CART CRS), Voluntary Health Services, Chennai, India.
Nagalingeswaran
N
Kumarasamy
Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.
Aimee
A
Freeman
University of Bordeaux, INSERM ISPED U1219, Bordeaux, France.
Nathalie
N
de Rekeneire
Department of Medical Informatics, School of Medicine, Vanderbilt University, Nashville, TN, USA.
Stephany N
SN
Duda
Centre for Infectious Disease Epidemiology and Research, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.
Mary-Ann
MA
Davies
Academic Model Providing Access to Healthcare, Eldoret, Kenya. pbraitstein@gmail.com.|Division of Epidemiology, University of Toronto, Dalla Lana School of Public Health, 155 College Street, Toronto, ON, M5T 3M7, Canada. pbraitstein@gmail.com.|Department of Medicine, School of Medicine, Moi University College of Health Sciences, Eldoret, Kenya. pbraitstein@gmail.com.
Paula
P
Braitstein
D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D044966:Anti-Retroviral Agents / Q000009:adverse effects*; D062313:Databases, Pharmaceutical; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D006801:Humans; D007391:International Cooperation; D060735:Pharmacovigilance
D044966:Anti-Retroviral Agents