SEPTEMBER 2008

IN THIS ISSUE

Please Select an Article to Read

• Australian Law Reform Commission’s Privacy Report – Health Update
• Special Commission of Inquiry into NSW Public Hospitals releases its First Report
• Pharmacists and Franchising
• Accessing funds in the current market environment
• Aged Care Update
• Amendments to the NSW Medical Practice Act introduce compulsory reporting of doctors for sexual misconduct, substance abuse and incompetent clinical practice
• Case note: Peer evidence as to competent medical practice
• Proposed changes to general requirements for labelling of medicines
• Windfall for Medical Insurers in Medical Malpractice Cases
• Protecting Root Cause Analysis in NSW private health facilities
• Case Note: Court Of Appeal reversal on Domestic Assistance Threshold under Civil Liability Act
• New procedures for Medical Negligence Claims in the NSW Supreme Court
• IVF Donors to lose anonymity under new legislation in New South Wales

 

Proposed changes to general requirements for labelling of medicines

The Therapeutic Goods Administration (TGA) has issued a proposed Therapeutic Goods Order No. 79 “General requirements for the labels for medicines” (TGO 79) to supersede existing TGO 69.  A guidance document to accompany draft TGO 79 is also proposed, to provide information about how the new order will take effect in practice.

Drafts of TGO 79 and the guidance document were made available by the Therapeutic Goods Committee for review and comment by stakeholders. Consultation closed on 29 February 2008 and further comment from the TGA is awaited.

The draft TGO 79 includes a two year transition period for labelling to comply with the amended provisions.  This transition period would commence upon TGO 79 being entered onto the Federal Register of Legislative Instruments.

The changes

TGO No. 69 “General requirements for labels for medicines” currently sets out the requirements in Australia for medicine labelling.

One material difference between TGO 69 and TGO 79 appears to be an inference that patient safety may be improved by declaring on the label or in a package insert excipients in medicines which are known to cause serious adverse reactions. If there is insufficient space on the label (and the medicine is included in schedule 4 or schedule 8 of the Poisons Standard), the excipients can be declared on a package insert. Column 2 of Schedule 1 of draft TGO 79 also specifies other information to be given on labels or inserts in some cases.
The guidance document to TGO 79 states that:

“Prescription medicines require excipient declarations on the label, or if there is insufficient space on the container or primary pack label, then declaration may be in a package insert.  Use of MIMS, PP Guide or Consumer Medicine Information (CMI) which is not supplied in the packet for excipient declarations for prescription medicines is no longer an acceptable alternative.”  

It is apparent however from a reading of p art 9(1) of draft TGO 79 that the label on a container and primary pack must only include an ingredient which is an excipient, if that ingredient is referred to in column 1 of schedule 1 of draft TGO 79.  This list is in general terms the same as the list of ingredients in the existing TGO 69, however it is broader in that it includes additional items such as crustacea, egg, fish, milk, sesame seeds and soya beans.

TGO 79 will involve a change for both:

1. healthcare professionals, as this medical information will be more accessible; and
2. sponsors, as costs will increase.

Implications

If a medicine contains any excipient on the list in Column 1 of Schedule 1 of TGO 79, and the ingredient must therefore be declared, some practical implications may need to be considered:

1. The option to supply a package insert will not be available to products which are only supplied in a bottle and are not contained in a carton.
2. It will no longer be sufficient for such specific ingredient information to be supplied by way of MIMS, PP Guide or CMI. These means have been used to provide labelling information other than on a bottle, and outside of a carton.
3. The additional labelling requirements for excipients will be more user- friendly for healthcare professionals administering medicines and will arguably improve safety.
4. However, the requirement is likely to increase the cost of the goods due to an increase in sponsor’s costs.  Some practical implications for sponsors to consider include :
   1. sponsors will need to incur the costs of printing additional information on containers or primary package labels, or printing package inserts and placing those inserts in the carton;
   2. greater logistical effort will be required to ensure that labels on containers, primary packs or package inserts are updated when changes to information occur.  Inventories will be needed to ensure sponsors are aware of which versions of leaflets are on which batches of product, or in which cartons .

Written by Ashley Holland, Partner, Norwest