An Evaluation of US Food and Drug Administration’s Program to Register HIV Drugs for Use in Resource-Constrained Settings

Chahal, Harinder Singh; Koukounas, Kalli; Capella, Peter; Presto, Ryan; Murray, Jeffrey; Shimer, Martin; Riley, Karen; Valdez, Mary Lou

doi:10.1001/jamanetworkopen.2019.15787

Cited by 2 publications

(1 citation statement)

References 9 publications

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“…Global health programmes usually rely on stringent regulatory authorities or the World Health Organization (WHO) prequalification programme to assure the quality of the products they are purchasing. This approach, along with special WHO programmes to expedite national registration based on WHO prequalification, successfully addresses the short-term goal of making products procured by global health programmes quickly available to address urgent needs [8]. However, strengthening national regulatory capacity to ensure that all medical products circulating in a country are safe, effective, and quality assured requires a much longer time commitment and more resources.…”

Section: Three Truthsmentioning

confidence: 99%

Integrating pharmaceutical systems strengthening in the current global health scenario: three ‘uncomfortable truths’

Hafner

Banda

Köhler

et al. 2020

J of Pharm Policy and Pract

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The response to emergency public health challenges such as HIV, TB, and malaria has been successful in mobilising resources and scaling up treatment for communicable diseases. However, many of the remaining challenges in improving access to and appropriate use of medicines and services require pharmaceutical systems strengthening. Incorporating pharmaceutical systems strengthening into global health programmes requires recognition of a few 'truths'. Systems strengthening is a lengthy and resource-intensive process that requires sustained engagement, which may not align with the short time frame for achieving targets in vertical-oriented programmes. Further, there is a lack of clarity on what key metrics associated with population and patient level outcomes should be tracked for systems strengthening interventions. This can hinder advocacy and communication with decision makers regarding health systems investments. Moving forward, it is important to find ways to balance the inherent tensions between the short-term focus on the efficiency of vertical programmes and broader, longer-term health and development objectives. Global health programme design should also shift away from a narrow view of medicines primarily as an input commodity to a more comprehensive view that recognizes the various structures and processes and their interactions within the broader health system that help ensure access to and appropriate use of medicines and related services.

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Section: Three Truthsmentioning

confidence: 99%

Integrating pharmaceutical systems strengthening in the current global health scenario: three ‘uncomfortable truths’

Hafner

Banda

Köhler

et al. 2020

J of Pharm Policy and Pract

View full text Add to dashboard Cite

show abstract

Role of pharmacists in improving accessibility of antiretrovirals to support the United States President's Emergency Plan for AIDS Relief: Impact on the patient, program, and market

Malati

2020

J Am Coll Clin Pharm

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The United States President's Emergency Plan for AIDS Relief (PEPFAR) is the largest commitment by any nation to combat a single disease through prevention and treatment initiatives; pharmacists play a critical role in improving the accessibility of antiretrovirals (ARVs). When determining the potential use of a medication for a human immunodeficiency virus (HIV) program, it is helpful to consider decisions through the (a) Perspective of a patient, (b) Perspective of the overarching HIV program providing care, and (c) Perspective of the ARV market. Pharmacists are uniquely positioned to contribute to decisions from these three perspectives. At the beginning of PEPFAR, the price of ARVs was cost prohibitive; however, after 17 years since its inception, through the work of pharmacists and other public health professionals, the price to treat one patient for one year is currently 63 USD. This article describes the impact of pharmacists at the U.S. Agency for International Development (USAID) and the Food and Drug Administration (FDA) in facilitating a dramatic reduction in the cost of ARVs, through the use of an expedited approval process and through pooling procurement of ARVs from a limited formulary.

show abstract

An Evaluation of US Food and Drug Administration’s Program to Register HIV Drugs for Use in Resource-Constrained Settings

Cited by 2 publications

References 9 publications

Integrating pharmaceutical systems strengthening in the current global health scenario: three ‘uncomfortable truths’

Integrating pharmaceutical systems strengthening in the current global health scenario: three ‘uncomfortable truths’

Role of pharmacists in improving accessibility of antiretrovirals to support the United States President's Emergency Plan for AIDS Relief: Impact on the patient, program, and market

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