SAS and AP support

THE Therapeutic Goods Administration’s (TGA’s) latest consultation: ‘Changes to accessing unapproved therapeutic goods through the Authorised Prescriber (AP) and Special Access Schemes (SAS)’ has received broad support from most respondents.

A submission from the Society of Hospital Pharmacists (SHPA) in conjunction with therapeutic advisory groups was one of 37 public submissions received.

That submission highlighted the need for health service facilities to be able to procure stock in advance of expected usage and supported an early move to an online system, with integration into prescribing and dispensing software planned for a second phase.

The SHPA also sought inclusion of suitable unregistered products that could meet a national emergency on the SAS Category B list.

The submission said the TGA should be responsible for comparative analyses of such products, their indications and their source and maintain “systematic communication” to health facilities around these details.

In addition, any drugs that can treat serious morbidity (such as loss of limb or blindness) should also be included on the SAS Category B notification list, the SHPA submission said.

Where an SAS product is to be used in a hospital setting, the Society would still insist that hospital Drug and Therapeutics Committees retain responsibility for vigilance.

Visit tga.gov.au for submissions.