Information for health professionals

Adverse reactions & reporting problems with medicines

Reporting adverse drug reactions

• Prepaid reporting form ("blue card")
  <http://www.tga.gov.au/adr/bluecard.htm>
• Report electronically
  <https://www.tgasime.health.gov.au/SIME/ADRS/ADRSRepo.nsf?OpenDatabase>
• Contact details for enquiries about adverse medicine reactions
  <http://www.tga.gov.au/problem/index.htm#medicines>
• Reporting problems with unapproved medicines: See Chapter 8, page 214, of Access to unapproved therapeutic goods in Australia <http://www.tga.gov.au/docs/html/unapp.htm> for requirements, criteria and timeframes for reporting adverse events and reactions associated with the use of unapproved medicines in Australia.

Other information about adverse reactions to medicines

• Australian Adverse Drug Reactions Bulletin
  <http://www.tga.gov.au/adr/aadrb.htm>
• Adverse drug reactions: frequently asked questions
  <http://www.tga.gov.au/adr/adrfaq.htm>
• Adverse drug reactions: what to report
  <http://www.tga.gov.au/adr/report.htm>
• Adverse drug reactions: what happens to a report
  <http://www.tga.gov.au/adr/rephap.htm>
• Adverse drug reactions: what information to include in a report
  <http://www.tga.gov.au/adr/repinfo.htm>

Information about medicines

• Medicines alerts & advisories
  <http://www.tga.gov.au/alerts/index.htm#medicines>
• Australian Adverse Drug Reactions Bulletin
  <http://www.tga.gov.au/adr/aadrb.htm>
• Prescribing medicines in pregnancy - An Australian categorisation of risk of drug use in pregnancy
  <http://www.tga.gov.au/docs/html/medpreg.htm>
• National Prescribing Service - Therapeutic Advice and Information Service
  Ph: 1300 138 677
  <http://www.nps.org.au>
  Drug information line for health professionals

Specific products/substances

• Analgesics: Safe use of paracetamol
  <http://www.tga.gov.au/docs/html/paracetpr.htm>
• Cough & cold medicines: TGA announcement regarding the use of cough and cold medicines in children
  <http://www.tga.gov.au/media/2008/080409cold.htm>
• Diethylstilboestrol (DES): Diethylstilboestrol (DES)
  <http://www.tga.gov.au/alerts/medicines/des1.htm>
• Heparin products: Heparin, clexane
  <http://www.tga.gov.au/alerts/heparin1.htm>
• Kava: Kava practitioner alert
  <http://www.tga.gov.au/docs/html/kavapa.htm>
• St John's Wort: St John's Wort - interactions with other medicines
  <http://www.tga.gov.au/docs/html/info.htm>
• Zolpidem: Zolpidem (Stilnox)
  <http://www.tga.gov.au/alerts/stilnox2.htm>

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Adverse events & reporting problems with medical devices

• Reporting form for use by medical device users (eg nurses, doctors, patients)
  <http://www.tga.gov.au/docs/html/forms/iris_udir.htm>
• Contact details for enquiries about adverse medical devices events
  <http://www.tga.gov.au/problem/index.htm#devices.htm>

Information about medical devices

• Medical devices alerts & advisories
  <http://www.tga.gov.au/alerts/index.htm#devices>
• Breast implant information booklet
  <http://www.tga.gov.au/docs/html/breasti.htm>
• The use of medical devices in alternative therapies
  <http://www.tga.gov.au/docs/html/devguid7.htm>
• Reducing the public health risks associated with reusable medical devices
  <http://www.tga.gov.au/devices/reusdev_phr.htm>

Advertising products & services

• Advertising medical services that include schedule 4 substances
  <http://www.tga.gov.au/docs/html/advsch4.htm>
  Points for medical practitioners and cosmetic/beauty therapists to consider when advertising services that involve therapeutic goods containing Schedule 4 substances
• Schedule 1 certificates
  <http://www.tga.gov.au/docs/html/advsch1.htm>
  Schedule 1 certificates are issued by healthcare practitioner associations to assist in identifying their members who are able to receive advertising material that is exempt from complying with the advertising requirements

Contact details for enquiries about accessing unapproved therapeutic products

If your enquiry is not specifically about access to unapproved therapeutic products, see: Contact the TGA

Enquiries about access to unapproved medicines

Includes Special Access Scheme, clinical trials, authorised prescribers, personal importation

• Email: eds@tga.gov.au
• Phone:
  • 02 6232 8111
  • 1800 020 653 (freecall within Australia)
  • Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
    • TTY or computer with modem users phone 1800 555 677 then ask for 1800 020 653
    • Speak and listen (speech to speech relay) users phone 1800 555 727 then ask for 1800 020 653
• Fax: 02 6232 8112
• Post: Drug Safety & Evaluation Branch, TGA, PO Box 100, Woden ACT 2606, Australia

Enquiries about access to unapproved medical devices

Includes Special Access Scheme, clinical trials

• Email: cab.medical.device.information@tga.gov.au
• Phone:
  • 1800 141 144 (freecall within Australia)
  • Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
    • TTY or computer with modem users phone 1800 555 677 then ask for 1800 020 653
    • Speak and listen (speech to speech relay) users phone 1800 555 727 then ask for 1800 020 653
• Fax: 02 6232 8785
• Post: Office of Devices, Blood & Tissues, TGA, PO Box 100, Woden ACT 2606, Australia

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