22 November 2004
Key Points:
The Therapeutic Goods Committee's Report goes some way towards addressing the deficiencies in current medicine labelling requirements, and the issues it raised established a dialogue with industry that recognised the need for change. Its notes and recommendations will play a part in the review of these issues presently being conducted by an expert Committee on Medicine Labelling.
The adequacy of current medicine labelling requirements was brought into question by the Pan Pharmaceuticals recall of April 2003, the largest medicines recall in Australia's history. Many consumers and retailers experienced difficulty in accurately identifying the recalled products; many products had similar names and consumers were unfamiliar with registration (AUST R) and listing (AUST L) numbers, batch numbers and other published details. In addition, Pan was the manufacturer and not the sponsor of many products recalled. The absence of the manufacturers' name from product labels, which is not a current requirement, was seen to contribute to the recall's problems.
It was considered that the Pan recall would have been made much easier if the manufacturer's name had been on product labels in addition to that of the sponsor or the supplier. As a consequence, the Government announced a proposed amendment to make mandatory the inclusion of manufacturer's details on labels of medicines, as part of reforms aimed at strengthening the therapeutic goods regulatory framework in the wake of Pan.
In March 2004, the Therapeutic Goods Committee (TGC) released a Report entitled "Medicine Labelling - Medicine Label Improvements to Assist Product Recall", which was aimed at, and succeeded in, generating comment from consumers, retailers, wholesalers, manufacturers and sponsors of therapeutic goods and health professionals on changes to medicine labelling requirements. Following those comments, the TGC released its recommendations in May.
In this article we explore the issues surrounding the proposed amendment and a number of additional proposals aimed at ensuring rapid and correct product identification at all levels during a recall, examine the reasons underlying the TGC's ultimate recommendation against the proposed amendment, and see what steps are currently being undertaken to resolve the issues raised in the TGC's Report.
Mandatory inclusion of manufacturers' details on medicine labels
Australian medicine labelling requirements are governed by Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69), a standard made under section 10 of the Therapeutic Goods Act 1989. The standard at present does not require that manufacturers' details appear on the labels of medicines. Before any amendment is made to TGO 69 to require these details, the TGC’s Report raised three main issues that need to be resolved.
The first issue is whether the proposed requirement to include manufacturers' details on labels should apply to all categories of medicines or only to a particular subset, such as listed medicines, complementary medicines, non-prescription medicines and/or prescription medicines. Some factors to consider include the number of manufacturers involved in producing different types of medicines, consumer expectations of labelling, a need for consistency across categories of medicines and the likelihood of recalls occurring in any specific products.
In acknowledging that multiple manufacturers may be involved in producing a single product, the second issue is which manufacturers should be included on the label to provide most assistance in a product recall? The TGC's Report found that a choice must be made between identifying all manufacturers, or one or more of the multiple manufacturers, based on these manufacturers undertaking specified steps in the manufacturing process.
Each choice has its limitations. Listing all manufacturers may not be feasible where there are space constraints or a different chain of manufacturers for each batch. More importantly, it may not increase the speed and ease of product identification during a recall should a large volume of information appear on the label.
The alternative - specifying one or more manufacturers on the basis of their undertaking particular steps in the manufacturing process - imports its own difficulties. Who is the most appropriate manufacturer to include? Guidelines would be needed, unless the named manufacturer is deemed to be the manufacturer of the final dosage form, or the manufacturer responsible for release of the product for supply. The TGC noted that the latter deemed manufacturer does not include Pan and would have been of no assistance in the Pan recall.
The third issue discussed in the TGC's Report was how, in practice, to determine the minimum amount of detail that will meet the needs of consumers, retailers and wholesalers. This presented a number of questions.
Following the consideration of industry responses to its Report, the TGC in a meeting on 4 May 2004 ultimately recommended that there be no mandatory requirement for manufacturers’ details to be included on medicine labels. It concluded that this would not improve the identification of medicines subject to recall, its reasons including increased consumer confusion, and the hindering of recall efforts where either a deemed manufacturer not responsible for the recall or multiple manufacturers appear on labels. The TGC's recommendation mirrors industry sentiment as most submissions to its Report opposed the Government's proposal.
Potential benefits and costs associated with the proposed change
The TGC's Report anticipated that potential benefits and costs, financial and other, would be incurred by sponsors in implementing new labelling requirements. The Report found that the main benefit of including manufacturers' details on medicine labels would be easy and accurate identification of a batch of a medicine by consumers, retailers and wholesalers during a recall. It was also of the view that considerable time saving for retailers and wholesalers and more prompt responses to consumer inquiries might result.
Having now considered industry submissions, the TGC cites the costs associated with amending labels for almost every medicine marketed in Australia as a reason against the proposed amendment. Financial costs may include the cost of new artwork for labels and any new equipment or modifications to existing equipment that may need to be made in order to apply the information.
Non-financial costs also weighed heavily on the TGC's recommendation against including manufacturers’ details on labels as it considered that this might compromise the space available for sponsors to include other information required for the safety and use of the product on the label, and cause reputation damage where a manufacturing problem results in a recall but the named manufacturer is not responsible.
Other possible changes to current labelling requirements to assist identification of medicines subject to recall
Recalls resulting from manufacturing problems usually affect only a specified number of batches of a product. Current medicine labelling requirements mandate information that enables a medicine to be identified to its batch level including product name, AUST R or AUST L number, batch number, expiry date and sponsor's or supplier's name and address. Ultimately, the TGC recommended that medicine labels currently include sufficient information to uniquely identify products subject to recall and that manufacturer's details need not be included on labels. However, as outlined below, in its Report, the TGC explored whether these current elements of identification could be improved to assist recalls.
Product name as a means of identifying medicines is given primary importance by TGO 69 where no concessions are made in the case of small containers or other packaging of small size. The Report considered this existing requirement to be sufficient for the purpose of facilitating recalls.
The AUST R or AUST L numbers are similarly required to appear on medicine labels without concession pursuant to both the Therapeutic Goods Regulations (Regulation 15) and TGO 69. However, the TGC in its Report found that a small minimum font size and the option to include the AUST R or AUST L number on either the main label or on a label securely affixed adjacent to the main label have created difficulties. The Report concluded that because the AUST R or AUST L number is a unique identifier that does not change from batch to batch, its presentation on medicine labels should be on both the container and primary packets of all medicines, on the main label and not on a separately affixed label, in the same orientation as the product name, in a larger font and in a colour contrasting with the background. The TGC's Report further suggested amending TGO 69 to prohibit the inclusion of other numbers, such as the sponsor's product line, on the main label of medicines to avoid confusion.
The batch number and expiry date are essential means of identification in the event of a recall given that many recalls affect only one batch or a number of batches of a medicine. In finding that complaints are frequently received by the TGA about difficulties reading batch numbers and expiry dates, the TGC's Report suggested that requirements for the presentation of batch numbers and expiry dates may need to be amended to improve their visibility and legibility.
The name and address of either the sponsor or supplier of the medicine currently must be included on both the container and primary pack labels. However, recall notifications issued by the TGA show only the sponsor's details and not that of the supplier. The TGC considered that amending the TGO 69 to require sponsor's details to always be included on labels, with the supplier's details allowable only in addition, would ensure a match between recall notifications and product labelling.
The TGC in its May meeting cited the possibility of alternative, more effective mechanisms to achieve efficient recalls as a reason against requiring manufacturers' details to be included on medicine labels. The TGC further noted in its meeting that the suggestions of stakeholders for improving existing medicine labelling requirements be considered carefully when developing the requirements for medicine labelling that will apply under the new trans-Tasman joint therapeutic products agency, which will replace Australia's TGA and New Zealand's MedSafe in 2005.
Other possible actions to assist in the identification of medicines subject to recall
The TGC in its Report identified two further actions that may be taken to improve the assistance of medicine labels during a recall.
The first action focussed on the ability of sponsors to identify batches of medicines subject to recall. The Pan recall, although unusually not a batch-based recall, revealed that not all sponsors tracked the manufacture of batches of medicines to allow them to be easily identified by the AUST R or AUST L number. Instead sponsors' tracking systems are often based on their own product numbers. The TGC's Report advocated that sponsors should ensure that record keeping systems are in place which readily identify products by the AUST R and AUST L number as well as by internal product/line numbers.
The second action centred upon taking steps to educate consumers and health professionals about the significance of the AUST R or AUST L number on a medicine. The Report of the TGC suggested this in light of the Pan recall where it was evident that many consumers and retailers were unaware that these numbers functioned as a key identifier by which medicines are sorted.
The TGC in its May meeting recommended that the first action be pursued by the TGA, that is, that the TGA take steps to ensure all sponsors maintain product records in a manner that will permit batches of medicines to be tracked easily, accurately and in a timely manner during a recall. These issues are also the subject of consideration in developing the requirements for medicine labelling to apply under the new Trans-Tasman agency in 2005.
Timing and transition arrangements
The TGC in its Report concluded that where TGO 69 is amended with the intention to improve product identification, there would be advantages if all amendments occurred simultaneously over the same transition period. This was ultimately recommended by the TGC in May as it would minimise disruption to sponsors and assist in educating consumers and health professionals about labelling changes.
In determining the length of the transition period, the Report found that transition periods of this nature had previously been based on time needed for sponsors to make changes to artwork once current labels had run out. A period of two years was not unusual for existing applications, whereas a much shorter time frame was more feasible for new applications.
Next steps
The TGC's Report goes some way towards addressing the deficiencies in current medicine labelling requirements, and the issues it raised established a dialogue with industry that recognised the need for change, but rejected the Government's proposed form of that change. In recommending that manufacturers’ details need not be required on medicine labels, the TGC noted alternative suggestions for change provided by stakeholders and recommended that the TGA rigorously ensure sponsors comply with existing requirements.
The TGC's notes and recommendations will play a part in the review of these issues presently being conducted by an expert Committee on Medicine Labelling. The Committee was appointed by the Therapeutic Products Interim Ministerial Council following the resolutions and recommendations made by the TGC in its May meeting. The terms of reference of the Committee are wider than the issues discussed in the TGC's Report, because the Committee must consider, and make recommendations to the Council and the TGC on, standards for the labelling of medicines to be applied by the new trans-Tasman agency. Ultimately the issues canvassed in this article will be decided upon by the new agency in finalising its Trans-Tasman Labelling Order prior to 1 July 2005.
It is hoped that the form of action that is finally taken to improve the ease and accuracy with which medicines are identified will ensure that a recall of Pan's scale, or indeed any recall at all, will take place rapidly and effectively in the interests of consumer health and safety.
For further information, please contact Robyn Baker.
