Be-cause Health & QUAMED literature updates

Ref (1): US Pharmacopoeia, Increasing Transparency in the Medicines Supply Chain, 2021

Ref (2): US Pharmacopoeia, Global Public Policy Position: Key Elements to Building a More Resilient Supply Chain

Dear Friend,

The more diffuse and fragmented the supply chain is, the greater the risk that important information about the origin, production volume, distribution chain, and integrity of products can be lost. Furthermore,  pre-existing vulnerabilities [such as the (too) geographically concentrated manufacturing and sourcing, poor-quality manufacturing, insufficient regulation, and lack of transparency] have been magnified by the COVID19 pandemic. If you are somehow involved in procurement, supply and quality of medicines and other health products in global health, you may be interested in these two short policy papers recently issued by the US Pharmacopoeia (USP).

The first one, Increasing Transparency in the Medicines Supply Chain, looks at how transparent information sharing can help to reduce vulnerabilities and to prevent or mitigate disruptions of quality-assured medicines in the global supply. It formulates recommendations for (a) the manufacturers, that should track and share information about types of medical products, production volumes, sources of raw ingredients and packaging materials, and distributors; (b) the regulators, that should access information on manufacturers’ sites, products, volume, and capacity, and share it with other regulators; and (c) pharmacies and hospital systems, that should track and share information about prescriptions, medications dispensed and any shortages. When possible, the information should be standardized. Furthermore, “voluntary arrangements may provide only a partial solution. Ultimately, in the absence of willingness to share, broader legal and policy changes are likely to be needed to overcome the current limits on sharing among regulators or the lack of requirements on industry to share.”

The second one, Key Elements to Building a More Resilient Supply Chain, lists and shortly discusses eleven “key elements for a more resilient supply chain”. These include:  foster more supply chain diversity  (relying on single suppliers always increases risks of shortages); establish a baseline of local, quality-assured production capacity; invest in more manufacturing capacity for critical medicines; invest in advanced technologies;  enable transparency and data sharing; enhance global cooperation; conduct crisis contingency planning and action (including for production lines and quality control); build and maintain critical medical product stockpiles; have plans for the resilience of distribution logistics; strengthen regulatory systems and quality assurance, and bolster quality assurance systems and adherence to public quality standards. This requires concerted action by all those in the supply chain, including manufacturers, distributors, policymakers, regulators, and public health experts. Failure to do so may seriously hamper the (national) capacity to timely deliver quality-assured medicines to all those in need, including during outbreaks and other public health emergencies.

Have a nice reading, and please share with concerned colleagues!

Raffaella

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