Back to Search
Start Over
Targeted Spontaneous Reporting: Assessing Opportunities to Conduct Routine Pharmacovigilance for Antiretroviral Treatment on an International Scale
- Source :
- Drug Safety
- Publication Year :
- 2016
-
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.
- Subjects :
- 0301 basic medicine
Program evaluation
medicine.medical_specialty
Drug-Related Side Effects and Adverse Reactions
Databases, Pharmaceutical
International Cooperation
Population
MEDLINE
Toxicology
03 medical and health sciences
Pharmacovigilance
0302 clinical medicine
Environmental health
Medicine
Adverse Drug Reaction Reporting Systems
Humans
Pharmacology (medical)
030212 general & internal medicine
Original Research Article
Data reporting
education
Intensive care medicine
Pharmacology
education.field_of_study
business.industry
fungi
030112 virology
Antiretroviral therapy
3. Good health
Anti-Retroviral Agents
Spontaneous reporting
business
Developed country
Subjects
Details
- ISSN :
- 11791942
- Volume :
- 39
- Issue :
- 10
- Database :
- OpenAIRE
- Journal :
- Drug safety
- Accession number :
- edsair.doi.dedup.....0a25ccbc32767b9a9db6877b6ecde11f