Pharmacy Daily | TGA issues performance snapshot

PHARMACISTS continue to make the highest number of medicine and vaccine adverse event reports to the Therapeutic Goods Administration (TGA) of any health profession.

The TGA's Jul to Dec 2020 Half Yearly Performance Snapshot revealed 12,815 adverse events were reported between 01 Jul and 31 Dec 2020, up from 12,295 in the same period in 2019.

Of the total number of cases reported in the second half of 2020, 4% (475) were withdrawn.

The 1,329 cases reported by pharmacists accounted for 54% of events the TGA was notified about by health practitioners, while doctors reported 569 cases, and nurses a further 363, with pharmaceutical companies reporting 7,978 incidents.

The average number of reports received by the TGA each week increased by 20 cases across the six months to 31 Dec 2020, to 493, compared with 473 in the prior corresponding period.

While the number of adverse events reported to the TGA increased in the second half of the year, the number of recalls issued by the regulator fell by 8% from 426 in the same timeframe in 2019, to 394 in 2020.

However medicine recall actions increased from 32 to 47, which the TGA said was "in part due to class wide recall actions for products containing the herbal ingredient, Fallopia multiflora, and non-prescription medicine, bufexamac".

Medical devices including in vitro diagnostic devices (IVDs) accounted for the largest number of recalls, 286, down from 326 in 2019.

The snapshot also noted that there were 658 new reports of medicines shortage in the six months to 31 Dec 2020, compared with 765 in the prior corresponding period in 2019.

Nov 2020 was the biggest month for new medicines shortage reports, with 123 notifications, while Oct 2020 saw the lowest number (82).

The TGA said the numbers only counted new reports, and did not include updates of previously reported shortages.

Manufacturer-related issues accounted for 38% of the new shortage notifications, while an unexpected increase in demand was behind 18% of cases, with commercial changes cited as the reason for 7.5% of incidents.