TGA last sought to improve the management of supply constraints with the 2014 adoption of the Medicine Shortages Information Initiative (MSII) and associated protocol. The MSII protocol asks sponsors to alert TGA “as soon as a medicine shortage is anticipated or known.” However, as participation in MSII is voluntary, the program has faIled to live up to expectations. “A significant number of shortages of extreme or high patient impact have not been reported by some sponsors. Instead, the first indication that the TGA received of these medicine shortages has in many cases been from correspondence from members of the community impacted by a shortage,” TGA wrote in its consultation. TGA tries to confirm drug shortages with the relevant sponsors after learning of them via other sources, but this can cause “significant delays.” The upshot is TGA is unable to support the search for alternative supplies of drugs from overseas or encourage the judicious use of remaining stocks of a medicine. TGA has spent the past eight months talking to the industry and government about how to better manage drug and vaccine shortages. That led to the new protocol that is now open for feedback. TGA wants sponsors to contact it when they learn of potential shortages “to facilitate early investigation with proactive forecasting and management.” If a shortage occurs unexpectedly, sponsors must contact TGA so it can conduct an urgent investigation. In cases when TGA contacts a sponsor about a shortage, the agency wants to receive a response within two business days. TGA is considering penalties for noncompliance. TGA will treat reports as confidential, but will publish details of supply constraints if they are deemed to have a “high” or “extreme” effect on patients. Information about such shortages will feature on the homepage of a revised MSII website. Sponsors of supply-constrained products with less impact on patients can refuse to allow TGA to publish details of the shortage. However, TGA will “strongly encourage” sponsors to allow the release of details of all shortages. The agency is now gathering feedback on its proposals. TGA wants to know whether people agree with its definition of a medicine shortage and the range of products to which the rules will apply. The agency is also seeking feedback on the proposed reporting timelines and a list of drugs that would automatically trigger a “high” or “extreme” risk warning when in short supply. More Information On RAPS