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Targeted Spontaneous Reporting: Assessing Opportunities to Conduct Routine Pharmacovigilance for Antiretroviral Treatment on an International Scale.
Drug Safety. 2016 Jun 9; 1-18.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.
The Fistula Fortnight: Healing Wounds, Renewing Hope, 21 February - 6 March 2005, Kano, Katsina, Kebbi and Sokoto States, Nigeria.
New York, New York, United Nations Population Fund [UNFPA], . 46 p.The Fistula Fortnight accomplished a number of goals: it mobilized resources for obstetric fistula and safe motherhood; increased public awareness that fistula is preventable; contributed to combating the marginalization of women who suffer from fistula; strengthened institutional capacity to manage fistula; and began to address the broader needs of women living with the disability. While the surgeries conducted represent only a small portion of the backlog, the Fistula Fortnight provided a strategic opportunity to raise awareness and motivate action among policymakers, national and local leaders, and the general public about the need to increase efforts to both prevent and treat fistula. (Excerpt)
Care of mother and baby at the health centre: a practical guide. Report of a technical working group.
Geneva, Switzerland, WHO, Division of Family Health, Maternal Health and Safe Motherhood Programme, 1994. , 55 p. (Safe Motherhood Practical Guide; WHO/FHE/MSM/94.2)This report is designed for health planners and program managers to improve access to health and to decentralize maternal and newborn health care. It covers secondary care services that traditional birth attendants (TBAs), midwives, and other nonphysician health workers in health centers can perform. Specifically, it defines the tasks and skills required to provide comprehensive care of mother and infant at the health center and in the community. It also looks at the role of the health center in training, supervision, and continuing logistic support for community based care. The first chapter examines the health center's role in maternal health and the 3 approaches to integrated care: vertical integration, integration across time, and horizontal integration. The next chapter reviews the essential elements of obstetric and neonatal care, including sexually transmitted diseases and HIV/AIDS. Topics discussed in the chapter on developing and maintaining a functional referral system include referral protocols, functional links with referral centers, obstetric first aid, maternity waiting homes, transport and communication, and reception of referred cases in referral centers. Institutional support mechanisms (chapter 4) are training; teamwork and supervision; logistics, maintenance, and essential drugs and supplies; management, communication, and interpersonal skills; and data collection and research. Topics included in the chapter on community support systems are TBA training and retraining, integrating the TBA into the health care system, IEC, and community support mechanisms for the health of mothers and newborns. The last chapter revolves around evaluation and monitoring, including estimating catchment area and coverage, monitoring quality of care for mothers and newborns, performance indicators, record keeping, and home-based maternal records.