TGA assists in Herron recall

The Australian public expects and demands that therapeutic goods be safe and of high quality. The Therapeutic Goods Administration (TGA) is responsible for ensuring the quality, safety, efficacy and timely availability of therapeutic goods to the Australian community.

The TGA evaluates new therapeutic products, prepares standards, develops test methods, conducts testing programs and liaises with industry to ensure that the therapeutic products available to consumers are of good quality, safe and effective. The TGA also undertakes licensing of Australian manufacturers of therapeutic goods and audits manufacturing procedures to ensure compliance with Good Manufacturing Practices.

That said, even with the best manufacturing procedures, mistakes and other unpredictable events, such as the recent tampering incident involving Herron manufactured paracetamol products, can result in defective or unsafe products being available for sale.

The TGA first became aware of the Herron incident on Thursday 16 March 2000 and immediately set up an internal task force consisting of members from the Recalls, Surveillance and Good Manufacturing Practice (GMP) and Audit Sections. Three TGA officers, two from Surveillance and one from Recalls, flew to Queensland to join a Task Force comprising Queensland Police, the TGA, Queensland Health and Herron. The Task Force advised on the identification of "at risk" product, coordination of the recall and developed an Action Plan for the eventual return of Herron products to the market.

As part of the overall program to eliminate the possibility that contamination had taken place prior to products being distributed from the Herron's premises, the TGA Laboratories undertook urgent analysis of 33 batches of Herron's retention samples of paracetamol.

Making full use of the laboratory's automated analytical equipment, all batches were successfully analysed and found to be free of strychnine. The samples were also tested for general compliance with normal quality control specifications including content of active substance and levels of degradation products. They were found to comply with specification limits for the range of tests performed.

The Over-the-Counter Medicines Evaluation Section and Listing Processing and Policy Unit worked closely with TGA personnel on site at Herron to facilitate changes to the packaging and labelling of Herron products, so newly manufactured products with enhanced product security can be distributed without undue delay.

The TGA completed a GMP audit of Herron's manufacturing facility. The audit was to ensure appropriate systems were in place to meet the Australian requirements for the manufacture of medicines. Based on the satisfactory audit result, the TGA will continue to licence Herron for the production of medicinal products.

Herron has followed the recommendations of the Task Force Action Plan. This encompasses the recall and destruction of all paracetomol products, review of Herron's manufacturing process and security, and the development of new easily distinguishable product with improved tamper evident packaging.

The Herron paracetamol recall resulted in the largest recall of therapeutic goods ever undertaken in Australia. As a result of this incident the TGA will be discussing with industry associations the desirability of having model crisis management guidelines in place.

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New edition of the Uniform Recall Procedure for Therapeutic Goods now available

The Uniform Recall Procedure for Therapeutic Goods <http://www.tga.gov.au/docs/html/urptg.htm> (URPTG) outlines the actions to be taken by sponsors and health authorities when therapeutic goods are removed from supply or subjected to corrective action for reasons relating to their quality, safety or efficacy. The URPTG is the result of an agreement between the therapeutic goods industry, the Commonwealth and State/Territory health authorities, consumers and the Consumer Affairs Division of the Department of Treasury (formerly the Federal Bureau for Consumer Affairs).

The December 1996 edition of the URPTG was recently reviewed by the TGA in consultation with the organisations mentioned above. The revised URPTG refers to 'medicine' instead of 'drug' and 'medical device' in place of 'therapeutic device'. Other amendments concern the inclusion of a description of a new recall provision under s.30B of the Therapeutic Goods Act 1989 (which provides for individual batches of a product to be recalled), and name changes of government departments and Ministers. There are also numerous changes in respect of names and contact details of individuals. The National Co-ordinating Committee on Therapeutic Goods has endorsed the revised URPTG and recommended that it be published as a January 2000 edition.

There were 216 recalls of therapeutic goods in Australia in 1997, 218 in 1998 and 229 in 1999. Approximately one third of the products recalled are medicines and two thirds are medical devices. Most medicine recalls require that affected products be recovered from pharmacies and other retailers, while most device recalls require that products be recovered from hospitals. In instances where it is necessary to try and stop all usage of a product, such as the Herron manufactured paracetamol products, a consumer level recall is conducted. There were 42 consumer level recalls in 1997, 14 in 1998 and 6 in 1999.

Progress on track for the review of drugs, poisons and controlled substances

The Report to the Council of Australian Governments for the National Competition Review of Drugs, Poisons and Controlled Substances Legislation is due for completion by the end of June. The report is being drafted using comments received in response to the Options Paper released last February.

The Review is required to make recommendations on a number of issues related to controls used for public health and safety protection in relation to drugs poisons and controlled substances. The controls have implications for the costs to industry, government, professionals and the community. The Review is concerned with reducing costs and improving the efficiency of the regulatory scheme.

The legislation controls are intended to allow access for the community while providing protection to the community, especially for children.

The Options Paper was released for public comment by the independent chair of the Review of Drugs, Poisons and Controlled Substances Legislation, Ms Rhonda Galbally. It contains options for regulating the way in which medicines, agricultural and veterinary chemicals and household poisons, including disinfectants are labelled, packaged, supplied and stored. These options were prepared using submissions from a range of interested parties, including health professionals, industry associations, regulatory bodies and consumer groups.

A total of 59 submissions were received by the Review Secretariat late last year, providing information to support the options set out. Copies of all submissions are available from the Secretariat for $50 to cover printing costs.

Some of the issues that have been addressed by stakeholders include:

Lack of uniformity between jurisdictions - Costs that have been identified include compliance costs to industry arising from variation between jurisdictions in areas such as labelling, sampling and advertising. Lack of uniformity in many areas is perceived as confusing and inefficient. It also makes cross border regulation and enforcement difficult.

Manner of supply - The supply of medicines over the Internet or by mail order is seen as a potential concern, requiring appropriate controls to protect consumers. Increased access to health care information on the Internet and decreased prices are seen as potential benefits for consumers. However, submissions have stated that supply in this way needs adequate counselling services to substitute for the face to face counselling and ensure quality use of medicines.

Concern was expressed about services to rural communities and the continued viability of pharmacies if alternative supply were to become widespread. Restricted access to health services was addressed as a concern.

Advertising - This issue has attracted mixed opinions, seen by some as warranting decreased regulation and by others as desirable to retain controls that are currently in place. Concern over whether or not advertising would provide balanced, understandable health information, and the possibility that increased advertising may lead to increased pressure on prescribers to prescribe advertised drugs were some of the issues addressed in submissions.

Scheduling - Another of the issues addressed is whether the Schedule 2 'Pharmacy Only' and Schedule 3 'Pharmacist Only' schedules should be retained or modified. The Review is considering the costs and benefits of retaining these restrictions and the likely costs and benefits of alternatives to these controls.