TGA Revises Proposed Mandatory Drug Shortage Reporting Scheme
Australia's Therapeutic Goods Administration (TGA) has revised its proposed mandatory reporting scheme for drug shortages in response to feedback gathered from public consultation in April.Under the mandatory reporting scheme, drugmakers would be required to report certain information about shortages within a set timeframe, with different reporting requirements for drugs included on a new "Medicines Watch List".
TGA says the watch list will include drugs of "critical importance" that, in the event of a shortage, could result in significant morbidity or patient death.
The new reporting scheme is intended to address the shortcomings of the country's current Medicine Shortages Information Initiative (MSII), a voluntary protocol for sponsors to alert TGA to known or anticipated shortages.
"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 said in the consultation documents.
While TGA says that "virtually all stakeholders supported the need for better management and timely communication of medicine shortages," industry stakeholders argued that the two-day reporting timetable for reporting shortages to the agency was too short.
To address industry concerns, TGA says it will still require sponsors to submit key information pertaining to the shortage within two business days but will give sponsors an additional three business days to provide the remaining information for watch list medicines and medicines deemed critically important. For other drugs, TGA says that sponsors must submit comprehensive information within 10 business days of becoming aware of a shortage.
“This will address industry's concerns and will maintain the timeliness sought by health professional groups for reporting of critical medicines shortages.” TGA writes.
TGA