Steps to ensure adequate supply of biological medicines: considerations for the healthcare provider

Mica, A.

doi:10.5639/gabij.2013.0203.038

Cited by 5 publications

(4 citation statements)

References 9 publications

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“…59 Supply chain security should also be considered; antitheft and anticounterfeiting measures decrease the risk of drug shortages and ensure product quality. 59,89…”

Section: Practical Considerations For the Use Of Biosimilars That Arementioning

confidence: 99%

“…59 Supply chain security should also be considered; antitheft and anticounterfeiting measures decrease the risk of drug shortages and ensure product quality. 59,89 Biologics are often administered to patients in hospital and physician office settings; therefore, biosimilar formulary review should also consider the logistics of product use in these settings. Any differences in product packaging (eg, vial size) and/or stability between biosimilar and reference products should be evaluated to determine the potential impact on product integrity and drug waste.…”

Section: Manufacturer Attributes and Logistics Of Product Usementioning

confidence: 99%

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Biosimilars: Practical Considerations for Pharmacists

et al. 2017

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“…59 Supply chain security should also be considered; antitheft and anticounterfeiting measures decrease the risk of drug shortages and ensure product quality. 59,89…”

Section: Practical Considerations For the Use Of Biosimilars That Arementioning

confidence: 99%

Section: Manufacturer Attributes and Logistics Of Product Usementioning

confidence: 99%

Biosimilars: Practical Considerations for Pharmacists

et al. 2017

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“…Furthermore, health care providers should assess a manufacturer’s capability to supply the product as one of the criteria included in the formulary review process. 60 …”

Section: Risk Of Future Biologics Shortagesmentioning

confidence: 99%

Development of biosimilars in an era of oncologic drug shortages

Li¹,

Subramanian²,

Anderson³

et al. 2015

DDDT

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Acute and chronic shortages of various pharmaceuticals and particularly of sterile injectable products are being reported on a global scale, prompting evaluation of more effective strategies to manage current shortages and development of new, high-quality pharmaceutical products to mitigate the risk of potential future shortages. Oncology drugs such as liposomal doxorubicin and 5-fluorouracil represent examples of first-choice drugs critically affected by shortages. Survey results indicate that the majority of hospitals and practicing oncologists have experienced drug shortages, which may have compromised patient safety and clinical outcomes, and increased health care costs, due to delays or changes in treatment regimens. Clinical trials evaluating novel agents in combination with standard-of-care drugs are also being affected by drug shortages. Clinical and ethical considerations on treatment objectives, drug indication, and availability of alternative options may help in prioritizing cancer patients involved in active drug shortages. The United States Food and Drug Administration and the European Medicines Agency have identified manufacturing problems, delays in supply, and lack of available active ingredients as the most frequent causes of recent or ongoing drug shortages, and have released specific guidance to monitor, manage, and reduce the risk of shortages. The upcoming loss of exclusivity for a number of anticancer biologics, together with the introduction of an abbreviated approval pathway for biosimilars, raises the question of whether these products will be vulnerable to shortages. Future supply by reliable manufacturers of well characterized biosimilar monoclonal antibodies, developed in compliance with regulatory and manufacturing guidelines and with substantial investments, may contribute to prevent future biologics shortages and ensure access to effective and safe treatment options for patients with cancer. Preclinical and clinical characterization is ongoing for potential biosimilars of trastuzumab, rituximab, and bevacizumab, with promising results.

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“…Another challenge is maintaining supply chains of medications used to treat rare diseases, which was not discussed in the annual meeting symposium. Manufacturers must demonstrate effective management of drug inventory, including raw material supplies, as well as multiple facilities to manufacture products with robust and secure distribution networks and work to improve processes and practices to anticipate events that may lead to disruptions in the drug supply chain . As with drug development in rare disease, there must be close communications among regulatory authorities, healthcare systems, and manufacturers to optimize availability of adequate supplies of medications.…”

mentioning

confidence: 99%

Don't Do Different Things…Do Things Differently! Drug Development in Rare Diseases

Rudek

Korth‐Bradley

2016

Clin Pharma and Therapeutics

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Although definitions of rare disease vary, most acknowledge that there are small numbers of affected patients compared with other conditions. Small numbers of patients, overlapping involvement of investigators as researchers and caregivers, as well as close relationships between researchers and manufacturers require a different pattern of drug development. Regulatory guidances for rare diseases are available, as well as ones for specific rare diseases. Maintaining drug supply for rare diseases also demands innovative approaches.

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Steps to ensure adequate supply of biological medicines: considerations for the healthcare provider

Cited by 5 publications

References 9 publications

Biosimilars: Practical Considerations for Pharmacists

Biosimilars: Practical Considerations for Pharmacists

Development of biosimilars in an era of oncologic drug shortages

Don't Do Different Things…Do Things Differently! Drug Development in Rare Diseases

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