Steps to ensure adequate supply of biological medicines: considerations for the healthcare provider
Journal Title: Generics and Biosimilars Initiative Journal - Year 2013, Vol 2, Issue 3
Abstract
Introduction: When drug shortages occur, healthcare providers (HCPs) often must ration drugs, cancel or delay treatments, or utilize alternative drugs that may be less efficacious and/or are associated with increased risk of adverse outcomes, potentially impacting patient care. The likelihood of drug shortages may be increased for biological medicines, which are produced in living cells, require complex manufacturing processes and rigorous regulatory compliance, and are sensitive to storage and handling conditions. Most of the drugs currently in short supply are relatively inexpensive generic sterile injectables. As many suppliers of generic drugs may begin to produce biosimilars in the future, the issue of biological drug shortages may become an important consideration. Discussion: This manuscript highlights critical supply chain parameters that HCPs should consider when evaluating a manufacturer’s ability to maintain and deliver a continuous supply of biological medicines. Parameters to consider include: 1) effective management of drug inventory; 2) active management of raw material suppliers and supplies; 3) maintenance of multiple facilities to manufacture products; 4) establishment and effective management of robust and secure distribution networks; and 5) continuous improvement in processes and practices to anticipate events that may lead to disruptions in the drug supply chain. Conclusion: Ensuring that approved biological medicines are available for adequate patient care through normal operations and during periods of supply shortages requires leveraging financial, technological and human resources. Proactive biological manufacturers invest in inventory and supply chain infrastructure to reduce the risk of drug shortages and shorten recovery times during a drug shortage, which should be a consideration by HCPs when making formulary decisions.
Authors and Affiliations
Andrew Mica, Martha Mutomba, Larry Green
Keywords
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- EP ID EP354897
- DOI 10.5639/gabij.2013.0203.038
- Views 91
- Downloads 0
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