Pharmacy on demand: New technologies to enable miniaturized and mobile drug manufacturing

Lewin, John J.; Choi, Eugene J.; Ling, Geoffrey

doi:10.2146/ajhp150639

Cited by 23 publications

(10 citation statements)

References 41 publications

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“…33 Advanced manufacturing technology such as pharmacy on demand also has the potential to revolutionize the manufacturing process, shifting away from traditional batch manufacturing methods to continuous-flow synthesis. 34 The technology has demonstrated the ability to reduce the time required to manufacture several different medications in a short period of time but will likely require additional research and investment.…”

Section: Laws and Legislationmentioning

confidence: 99%

The U.S. medicine chest: Understanding the U.S. pharmaceutical supply chain and the role of the pharmacist

Costantino¹

2021

Journal of the American Pharmacists Association

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The U.S. capacity to manufacture key essential medications has diminished. The U.S. pharmaceutical supply chain (USPSC) has diversified and now relies on international sources of active pharmaceutical ingredients and finished drug products (FDPs). Despite years of effort raising concerns about the USPSC, pharmacists and pharmacy technicians continue to spend a substantial amount of time and energy responding to, and mitigating the impact of, medication shortages, drug recalls, and the adverse outcomes related to low-quality medications. The extent of U.S. reliance on foreign sources of medications is largely unknown. Pharmacists do not have a reliable way to determine the country of origin (i.e., source), capacity, or geographic location of pharmaceutical manufacturers, limiting our ability to anticipate challenges or mitigate risks to our Nation’s drug supply. The U.S. Food and Drug Administration’s task of regulating quality and safety is challenging and will likely require additional safeguards and resources. In addition to pharmacists’ engagement, solutions will likely need to leverage a mix of policy, economic incentives, and expanded objective surveillance testing. The U.S. pharmaceutical supply chain is complex, global, and goes beyond FDPs. The 2020 American Pharmacists Association House of Delegates has rightly asserted that “The quality and safety of pharmaceutical and other medical products and the global pharmaceutical and medical product supply chain are essential to the United States national security and public health.” Pharmacy professionals on the front line engage with patients, identify medication-related issues, and engage in drug-procurement decisions. Pharmacists are essential to our nation’s overall health and must be engaged in the development and implementation of strategies to safeguard the USPSC.

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Section: Laws and Legislationmentioning

confidence: 99%

The U.S. medicine chest: Understanding the U.S. pharmaceutical supply chain and the role of the pharmacist

Costantino¹

2021

Journal of the American Pharmacists Association

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“…Magistral preparation of smallmolecule drugs and radiopharmaceuticals is a skill practiced by many hospital pharmacists today. Considering the acceptance of in-hospital production of advanced therapy medicinal products (ATMPs) like complex gene and cell therapies in the EU [3], local production even of otherwise highly expensive or personalized biologicals lies on the horizon [4][5][6]. However, such a new practice will give rise to regulatory and ethical complexities and might require a completely new type of governance.…”

Section: Pushing the Regulatory Boundariesmentioning

confidence: 99%

In-Hospital Production of Medicines: Preparing for Disruption

Kalkman

Arentshorst

Hoekman

et al. 2020

Trends in Biotechnology

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“…The appearance of new pharmaceutical companies, the emerging market of low-priced generics and biosimilars, and their support by the health authorities are the major driving forces decreasing the prices [31]. Additionally, the new, fast changing market of low-volume production also strengthen the need of transitioning towards scalable, flexible and multi-product lines, due to the emerging popularity of personalized medicine, battlefield medicine and production on demand [32,33]. Hence, cutting costs is essential, various strategies have been developed to meet this need.…”

Section: Current Trends Needs and Expectations In The Bioindustrymentioning

confidence: 99%

Advancement of sensor technology for monitoring and control of upstream bioprocesses

Randek

2020

Linköping Studies in Science and Technology. Dissertations

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Pharmacy on demand: New technologies to enable miniaturized and mobile drug manufacturing

Abstract: Modular platforms under development by DARPA's Battlefield Medicine program may one day improve the safety, efficiency, and timeliness of drug manufacturing.

Cited by 23 publications

References 41 publications

The U.S. medicine chest: Understanding the U.S. pharmaceutical supply chain and the role of the pharmacist

The U.S. medicine chest: Understanding the U.S. pharmaceutical supply chain and the role of the pharmacist

In-Hospital Production of Medicines: Preparing for Disruption

Advancement of sensor technology for monitoring and control of upstream bioprocesses

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