Benzylpenicillin Caspofungin Cefepime Cefotaxime Ceftazidime Ceftriaxone Chloramphenicol (IV) Ciprofloxacin Colistin Daptomycin Dicloxacillin Erythromycin (IV) Flucloxacillin Ganciclovir Gentamicin (IV) Imipenem/cilastatin Linezolid Meropenem Metronidazole (IV) Piperacillin/tazobactam Posaconazole Rifabutin Rifampicin Teicoplanin Activated charcoal Atropine injection Desferrioxamine injection Digoxin specific antibodies Edetate calcium disodium (EDTA) Ethanol injection Flumazenil Folinic acid (calcium folinate) injection Fomepizole Idarucizumab Methylene blue injection N- Acetylcysteine injection Naloxone injection Pralidoxime injection Sodium nitrite injection Sodium thiosulphate injection Emergency and Critical Care Adrenaline Alteplase Amiodarone Benztropine injection Calcium chloride 1 g/10 mL* Calcium gluconate gel Icatibant Intravenous emulsion 20%* Ketamine Lignocaine Noradrenaline Octreotide Propofol Sodium bicarbonate 100 mmol/100 mL* Tranexamic acid Vitamin K (IV) Other Dantrolene injection Desmopressin Enoxaparin Heparin Oxytocin Quinine injection Rasburicase * Specific concentrations are included for these products as they are they are used in specific emergency situations. National immunisation program vaccines Any vaccine on the NIP that includes the following: Hepatitis A Hepatitis B Diphtheria Tetanus Meningococcal B Meningococcal A Meningococcal W Meningococcal Y Specific Immunoglobulins CMV immunoglobulin Rh(D) immunoglobulin snake antivenom Funnel web spider antivenom S3 medicines Adrenaline injection Chloramphenicol Glyceryl trinitrate Macrogols
3. Substantial civil penalties and criminal offence Civil penalty for failing to report a medicine shortage: Maximum civil penalty: for an individual – 3,000 penalty units; and for a body corporate – 30,000 penalty units. Criminal offence for failing to report a medicine shortage: Penalty: Imprisonment for 12 months or 1,000 penalty units, or both. This option would also include publishing the names of sponsors who do not comply with the mandatory reporting requirements on the TGA website (and potentially in other media), and the issuing of an infringement notice for a contravention in most circumstances (in the amount of up to 60 penalty units for a body corporate), and publication of the notice on the TGA website. The maximum amounts for the penalties in this option are equivalent to those imposed under existing sections 29A and 29AA of the TG Act for failing to notify the Secretary of information relating to adverse effects of registered or listed therapeutic goods that a sponsor is aware of. Section 29A creates a criminal offence and under section 29AA the person is liable to a civil penalty for such conduct; Subsection 4K(2) of the Crimes Act 1914 would apply (this creates a daily or continuing offence for each day the person is in breach after the day on which the person must take the required action – ie in this case reporting the medicine shortage); New section 42YCA of the Act would also apply under this option (this provides for daily civil penalties for each day of contravention after the day on which the person must take the required action – ie in this case reporting the medicine shortage); Where the offender is a body corporate, its executive officers could potentially be personally liable, in accordance with section 54B of the Act; The maximum amount of the potential penalties under this option would be more substantial, and may not be consistent with a regime in which repeated non-compliance is expected to be rare; The non-reporting of medicine shortages may not be directly analogous to the non-reporting of the adverse effects of medicines, particularly in relation to whether harm to a person is, or may be, directly related to the non-reporting; Criminal offences may not necessarily be the most effective sanction the
majority of participants in the prescription medicines and vaccines market are body corporates. Options 2 and 3 are more aligned to Canada’s enforcement approach which takes a graduated, risk-based approach, in which available regulatory measures range from public warnings or advisories to investigation and referral for prosecution of an offence, with applicable fines and penalties. The UK is also proposing significant financial penalties for non-reporting of medicine shortages. For consideration PROPOSED COMPLIANCE: Three options are presented in the table above. SOME QUESTIONS TO CONSIDER: Do you support particular options? Why? Which option, or combination of options, do you believe would be the most effective?