Implementation of the Ebola Virus Persistence in Ocular Tissues and Fluids (EVICT) study: Lessons learned for vision health systems strengthening in Sierra Leone.

BACKGROUND: Following the West African Ebola virus disease (EVD) outbreak of 2013-2016 and more recent EVD outbreaks in the Democratic Republic of Congo, thousands of EVD survivors are at-risk for sequelae including uveitis, which can lead to unremitting inflammation and vision loss from cataract. Because of the known risk of Ebola virus persistence in ocular fluid and the need to provide vision-restorative, safe cataract surgery, the Ebola Virus Persistence in Ocular Tissues and Fluids (EVICT) Study was implemented in Sierra Leone. During implementation of this multi-national study, challenges included regulatory approvals, mobilization, community engagement, infection prevention and control, and collaboration between multiple disciplines. In this report, we address the multifacted approach to address these challenges and the impact of implementation science research to address an urgent clinical subspecialty need in an outbreak setting. METHODOLOGY/PRINCIPAL FINDINGS: Given the patient care need to develop a protocol to evaluate ocular fluid for Ebola virus RNA persistence prior to cataract surgery, as well as protocols to provide reassurance to ophthalmologists caring for EVD survivors with cataracts, the EVICT study was designed and implemented through the work of the Ministry of Health, Sierra Leone National Eye Programme, and international partnerships. The EVICT study showed that all 50 patients who underwent ocular fluid sampling at 19 and 34 months, respectively, tested negative for Ebola virus RNA. Thirty-four patients underwent successful cataract surgery with visual acuity improvement. Here we describe the methodology for study implementation, challenges encountered, and key issues that impacted EVD vision care in the immediate aftermath of the EVD outbreak. Key aspects of the EVICT study included defining the pertinent questions and clinical need, partnership alignment with key stakeholders, community engagement with EVD survivor associations, in-country and international regulatory approvals, study site design for infection prevention and control, and thorough plans for EVD survivor follow-up care and monitoring. Challenges encountered included patient mobilization owing to transportation routes and distance of patients in rural districts. Strong in-country partnerships and multiple international organizations overcame these challenges so that lessons learned could be applied for future EVD outbreaks in West and Central Africa including EVD outbreaks that are ongoing in Guinea and Democratic Republic of Congo. CONCLUSIONS/SIGNIFICANCE: The EVICT Study showed that cataract surgery with a protocol-driven approach was safe and vision-restorative for EVD survivors, which provided guidance for EVD ophthalmic surgical care. Ophthalmologic care remains a key aspect of the public health response for EVD outbreaks but requires a meticulous, yet partnered approach with international and local in-country partners. Future efforts may build on this framework for clinical care and to improve our understanding of ophthalmic sequelae, develop treatment paradigms for EVD survivors, and strengthen vision health systems in resource-limited settings.

Dispensing with conscience: a legal and ethical assessment.

BACKGROUND: For over 30 years, pharmacists have exercised the right to dispense medications in accordance with moral convictions based upon a Judeo-Christian ethic. What many of these practitioners see as an apparent shift away from this time-honored ethic has resulted in a challenge to this right. OBJECTIVE: To review and analyze pharmacy practice standards, legal proceedings, and ethical principles behind conflicts of conscientious objection in dispensing drugs used for emergency contraception. DATA SOURCES: We first searched the terms conscience and clause and Plan B and contraception and abortion using Google, Yahoo, and Microsoft Networks (2006-September 26, 2008). Second, we used Medscape to search professional pharmacy and other medical journals, restricting our terms to conscience, Plan B, contraceptives, and abortifacients. Finally, we employed Loislaw, an online legal archiving service, and did a global search on the phrase conscience clause to determine the status of the legal discussion. DATA SYNTHESIS: To date, conflicts in conscientious objection have arisen when a pharmacist believes that dispensing an oral contraceptive violates his or her moral understanding for the promotion of human life. Up to this time, cases in pharmacy have involved only practitioners from orthodox Christian faith communities, primarily devout Roman Catholics. A pharmacist's right to refuse the dispensing of abortifacients for birth control according to moral conscience over against a woman's right to reproductive birth control has created a conflict that has yet to be reconciled by licensing agents, professional standards, or courts of law. CONCLUSIONS: Our analysis of prominent conflicts suggests that the underlying worldviews between factions make compromise improbable. Risks and liabilities are dependent upon compliance with evolving state laws, specific disclosure of a pharmacist's moral objections, and professionalism in the handling of volatile situations. Objecting pharmacists and their employers should have clear policies and procedures in place to minimize workplace conflicts and maximize patient care.