United States Food and Drug Administration and Department of Defense Shelf-Life Extension Program of Pharmaceutical Products: Progress and Promise

Khan, Saeed R.; Kona, Ravikanth; Faustino, Patrick J.; Gupta, Abhay; Taylor, Jeb S.; Porter, Donna A.; Khan, Mansoor A.

doi:10.1002/jps.23925

Cited by 31 publications

(18 citation statements)

References 2 publications

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“…However, actual use (and some guidelines) suggests a reliable performance outside these specifications 87 and identical products from different manufacturers have different storage and shelf life requirements. Therefore, in line with current practice for pharmaceutical products, 88 extended product stability testing (including temperature and storage stability) should be done to confirm the true limits in low-resource settings.…”

Section: Availability Of Equipment and Consumables Adapted For Use Inmentioning

confidence: 99%

Clinical bacteriology in low-resource settings: today's solutions

Ombelet

Ronat

Walsh

et al. 2018

The Lancet Infectious Diseases

137

159

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Low-resource settings are disproportionately burdened by infectious diseases and antimicrobial resistance. Good quality clinical bacteriology through a well functioning reference laboratory network is necessary for effective resistance control, but low-resource settings face infrastructural, technical, and behavioural challenges in the implementation of clinical bacteriology. In this Personal View, we explore what constitutes successful implementation of clinical bacteriology in low-resource settings and describe a framework for implementation that is suitable for general referral hospitals in low-income and middle-income countries with a moderate infrastructure. Most microbiological techniques and equipment are not developed for the specific needs of such settings. Pending the arrival of a new generation diagnostics for these settings, we suggest focus on improving, adapting, and implementing conventional, culture-based techniques. Priorities in low-resource settings include harmonised, quality assured, and tropicalised equipment, consumables, and techniques, and rationalised bacterial identification and testing for antimicrobial resistance. Diagnostics should be integrated into clinical care and patient management; clinically relevant specimens must be appropriately selected and prioritised. Open-access training materials and information management tools should be developed. Also important is the need for onsite validation and field adoption of diagnostics in low-resource settings, with considerable shortening of the time between development and implementation of diagnostics. We argue that the implementation of clinical bacteriology in low-resource settings improves patient management, provides valuable surveillance for local antibiotic treatment guidelines and national policies, and supports containment of antimicrobial resistance and the prevention and control of hospital-acquired infections.

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Section: Availability Of Equipment and Consumables Adapted For Use Inmentioning

confidence: 99%

Clinical bacteriology in low-resource settings: today's solutions

Ombelet

Ronat

Walsh

et al. 2018

The Lancet Infectious Diseases

137

159

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“…A recent study has shown that each dollar spent on SLEP results in $13 to $94 saved on reacquisition costs [2]. For many years, the FDA's Detroit field laboratory has been an important partner with the Center for Drug Evaluation and Research in the analysis of various medical products stored (https://chemm.nlm.nih.gov/chempack.htm) for the DoD as part of the Strategic National Stockpile (SNS) program [3].…”

Section: Introductionmentioning

confidence: 99%

“…Drugs tested in this program range from antibiotics to antidotes for various poisoning agents [3]. One of the important medical products that have been analyzed by FDA is ATNAA (Antidote Treatment Nerve Agent Auto-Injector), which is currently being stockpiled by the military (http://archive.defense.gov/news/newsarticle.aspx?id=120780) for the treatment of nerve agent intoxication, such as organophosphorus nerve agent poisoning.…”

Section: Introductionmentioning

confidence: 99%

Development and Application of a Validated UHPLC Method for the Determination of Atropine and Its Major Impurities in Antidote Treatment Nerve Agent Auto-Injectors (ATNAA) Stored in the Strategic National Stockpiles

Yen¹,

Mohammad²,

Schneider³

et al. 2017

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The development and implementation of advanced analytical technologies is essential for extending the expiry for complex drug products stored in the Strategic National Stockpiles. Consequently, a novel Ultra High-Performance Liquid Chromatographic (UHPLC) method has been developed for the analysis of atropine and its respective impurities to support the analytical research platform for auto-injectors. This study is part of a larger research effort to improve the efficiency and broaden the applicability of advanced analytical methods for medical counter-measure medications. The current HPLC compendial methodology for atropine sulfate injection requires an analysis time of 40 minutes for atropine. In comparison, the novel gradient UHPLC method required only 8 minutes to evaluate both atropine and its major pharmaceutical impurities. Improved separation was achieved on a Waters Acquity UHPLC BEH C18 1.7 µm, 2.1 × 100 mm column employing gradient elution of mobile phase solvent A (0.1% H 3 PO 4 ) and solvent B (0.1% H 3 PO 4 , 90% ACN, and 10% H 2 O). The method was validated according to USP Category I requirements for assay. The daily standard calibration curves were linear over a concentration range from 50 μg/mL to 250 μg/mL with a correlation coefficient of >0.999. The detection limit (LOD) and quantitation limit (LOQ) were 3.9 μg/ml and 13.1 μg/ml, respectively. Resolution results indicate that atropine and the following impurities, degradants and a preservative can also be separated and analyzed using this proposed method: noratropine, 4,4'-di-hy- 16droxydiphenyl ether, 2,4'-dihydroxydiphenyl ether, 4-bromophenol, 4-hydroxyatropine, tropic acid, apoatropine HCl, atropic acid, hydroquinone, nitroethane, phenol and catechol. The UHPLC method demonstrated enhanced selectivity and significantly reduced the analysis time when compared with the traditional USP compendial HPLC method. The method was successfully applied to the evaluation of atropine in ATNAA auto-injectors lots from the Strategic National Stockpiles.

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“…Formal programs are in place to extend the manufacturer-assigned shelf life for stockpiled phar-maceuticals, since it has been empirically demonstrated that their actual shelf life can be much longer if they are stored properly. 14,15 The motivation to develop and implement the pharmaceutical Shelf-Life Extension Program (SLEP) emerged during the mid-1980s when the military realized that extending the shelf life of medicines could help solve the supply and demand challenges they experienced. 14 Since its adoption, SLEP has proved to be effective at reducing the logistical burden and replacement costs of valuable medical assets held in US stockpiles.…”

mentioning

confidence: 99%

“…14 Since its adoption, SLEP has proved to be effective at reducing the logistical burden and replacement costs of valuable medical assets held in US stockpiles. 14,15 An important contributor to the success of this program, however, was verification of product quality prior to shelf-life extensions being granted. In the context of stockpiled PPE, the paucity of research and initiatives related to quality assurance may be a hindrance in the development of a PPE-tailored SLEP.…”

mentioning

confidence: 99%

Quality Assurance Sampling Plans in US Stockpiles for Personal Protective Equipment

Yorio

Rottach

Dubaniewicz³

2019

Health Security

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Personal protective equipment (PPE) stockpiles in the United States were established to facilitate rapid deployment of medical assets to sites affected by public health emergencies. Large quantities of PPE were introduced into US stockpiles because of the need to protect healthcare and other professionals during these events. Because most stockpiled PPE was acquired during, or immediately following, large-scale public health events, such as pandemic influenza planning (2005)(2006)(2007)(2008), SARS (2003), H1N1 (2009-10), and Ebola (2014-15), aging PPE poses a significant problem. PPE such as N95 filtering face piece respirators were not designed to be stored for long periods, and much of the currently stored PPE has exceeded its manufacturer-assigned shelf life. Given the significant investment in the procurement and storage of PPE, along with projections of consumption during public health emergencies, discarding large quantities of potentially viable PPE is not an attractive option. Although shelf-life extension programs exist for other stockpiled medical assets, no such option is currently available for stockpiled PPE. This article posits stockpile quality assurance sampling plans as a mechanism through which shelf-life extension programs for stockpiled PPE may be achieved. We discuss some of the nuances that should be considered when developing a plan tailored to stockpiles and provide basic decision tools that may be used in the context of a quality assurance program tailored to stockpiled PPE. We also explore basic information by comparing and contrasting different sample size options. STOCKPILES REPRESENT an important component of the United States' public health infrastructure and are a strategic component of many federal, state, and local public health agencies. 1,2 Throughout the United States, stockpiles were established to store large quantities of inventory to quickly supply healthcare and emergency response professionals responding to public health events. The placement of stockpiles in strategic locations

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United States Food and Drug Administration and Department of Defense Shelf-Life Extension Program of Pharmaceutical Products: Progress and Promise

Cited by 31 publications

References 2 publications

Clinical bacteriology in low-resource settings: today's solutions

Clinical bacteriology in low-resource settings: today's solutions

Development and Application of a Validated UHPLC Method for the Determination of Atropine and Its Major Impurities in Antidote Treatment Nerve Agent Auto-Injectors (ATNAA) Stored in the Strategic National Stockpiles

Quality Assurance Sampling Plans in US Stockpiles for Personal Protective Equipment

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