Rising number of issues


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The numbers of medicine recalls and reported shortages increased substantially during the second half of 2019

Australian pharmacists were active in reporting medicine adverse events, and the number of medicine recalls and shortages rose substantially in the second half of 2019, the Therapeutic Goods Administration says.

In it’s “Half Yearly Performance Snapshot: 1 July to 31 December 2019“, published today (6/5), the TGA has released data on a range of its activities during the six month period.

The report revealed there were 12,295 medicine and vaccine adverse event reports between July and December 2019. The number of reports received was similar to the same period in 2018.

Health professionals reported 2,321 (20%) of accepted cases, with pharmacists the most common health professional reporter type (48%). In total, 1123 reports were made by pharmacists, an increase from 900 in the second half of 2018.

Nearly two-thirds (64%) of reports were received from sponsors.

The data showed the impact of mandatory reporting on the quantity of medicine shortage reports during the period under review. 

The number of medicine shortages reported to the TGA “greatly increased as a result of the implementation of mandatory reporting,” the agency said, with 765 reported shortages during July to December 2019, compared to 403 for the same period in 2018.

Since 1 January 2019, sponsors of prescription medicines and some over-the-counter medicines have been required to report all shortages or discontinuations of their products to the TGA.

Also rising sharply was the amount of recall activity, with a “significant increase” (23%) reported from the previous six-monthly reporting period (426 in July to December 2019 compared to 347 in the same period in 2018).

This was common across three of the four product categories (medicines, medical devices, bloods, but not biologicals). Medicine recalls were up from 19 in the second half of 2018 to 32 in the same period of 2019.

“Whilst showing an overall increase in volume, proportionally, each product category has remained relatively consistent with the previous period,” the report found.

Meanwhile, the TGA said its regulatory compliance focus in this period was “on areas of alleged non-compliance relating to products used in cosmetic procedures and the import, manufacture, supply and advertising of peptides and Selective Androgen Receptor Modulators (SARMs)”.

“Two referrals were made to the Commonwealth Department of Public Prosecutions, with 184 alleged offences representing the largest case referred by the TGA. A civil court proceeding was also concluded. There was a significant increase in the use of infringement notices as an alternative to court action”.

In total 1118 prescription medicines, 65 OTC medicines, 5 biological products and 217 complementary and homeopathic products were investigated during the period under review.

Medicine approvals

  • Prescription medicines – 185 Category 1 and Comparable Overseas Regulator (including 22 New Chemical Entities and 36 new generic medicines), and 743 Category 3 applications were approved.
  • Over-the-counter medicines – 78 new OTC medicine applications (N1 to N5) during this period, which was similar to the previous six months (82).
    The number of approved applications to change existing medicines (C2 to C4; 380) increased in comparison to the previous six months (340).
  • Listed medicines – the number of new applications increased by 21% in July to December 2019
    (1,141) compared with the same period in 2018 (943), and is likely as a result of sponsors transitioning to permitted indications. A higher number of Registered Complementary Medicine variation applications were approved during this period. The majority were for label variations to comply with the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines.
  • The number of compliance reviews that were completed in this period (105) was higher than for the same period in 2018 (57). This increase is mainly due to targeting of medicines with potential high-risk compliance issues identified through internal data analytics.

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