Adverse medicines reactions

SSRIs

• Media release advising pregnant women who are taking the antidepressant, Paroxetine, to discuss this treatment with their doctor <http://www.tga.gov.au/media/2005/050907-paroxetine.htm>, following some new information from overseas that suggests there may be a slight increased risk to their babies
• Information sheets on the use of SSRI antidepressants by pregnant women <http://www.tga.gov.au/alerts/ssri.htm>

Adverse drug reactions bulletin

The August and October 2005 issues of the Australian Adverse Drug Reactions Bulletin <http://www.tga.gov.au/adr/aadrb.htm> are available.

Articles in the October issue include:

• Inadvertent paracetamol overdose
• Please report paediatric adverse reactions
• Screening guidelines for women exposed to DES in utero
• Retirement of Dr John McEwen

Articles in the August issue include:

• Suicidality with SSRIs: adults and children
• Ezetimibe and muscle disorders
• Pathological gambling with cabergoline
• Reporting problems with products other than medicines

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Deadline for updating 'grandfather' products extended

The deadline for 'fee free' updates to details of registered OTC and complementary medicines in the Australian Register of Therapeutic Goods (ARTG) has been extended from 31 December 2005 to 31 March 2006.

Sponsors are encouraged to use the OPAL system to verify and, if necessary, update their ARTG records at the earliest opportunity. The intention is to ensure that all ARTG data are current, accurate and complete before the commencement of the joint agency on 1 July 2006.

The joint-agency-equivalent of the OPAL system will not accept applications for joint agency licences for Australian products that have not been updated via OPAL. After the 'fee free' period ends on 31 March 2006, sponsors must pay a lodgement fee (currently $790) for each product to be updated.

A step-by-step guide to the update of registered OTC and complementary medicines using OPAL <http://www.tga.gov.au/npmeds/otc_infosheet.htm> is available. For more detailed information, call the OPAL Help Desk on 1800 616 011.

DSEB workflow practices

The Drug Safety and Evaluation Branch recently engaged the services of a consultant to provide advice on the most appropriate means for improving workflow practices within the DSEB.

Following an initial exploration of some of the issues, a discussion paper has been prepared to provide a basis for further discussions with stakeholders.

Because the feedback from this consultation will also flow through into the development of business practices for the joint agency, feedback is being sought from both New Zealand and Australian stakeholders.

The discussion paper and details of face-to-face forums that will be held in Australia and New Zealand <http://www.anztpa.org/consult/workpractices.htm> are on the Trans Tasman Therapeutic Products Agency Project Internet site.

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European Union guidelines

Since the last issue of TGA News, 7 new EU Guidelines have been adopted in Australia. See: EU Guidelines - What's Newly Published <http://www.tga.gov.au/docs/html/euguideh.htm#eugwnp>

Extemporaneous compounding

In late 2004, the TGA commissioned a review on the growth in the practice of extemporaneous compounding and the concerns that this had caused the National Co-ordinating Committee on Therapeutic Goods (NCCTG). The report has been reviewed by the NCCTG and by the Australian Health Ministers' Advisory Council (AHMAC). The AHMAC acknowledged that public health concerns existed and endorsed continued development by the NCCTG, in consultation with stakeholders, of an appropriate regulatory response for managing health and safety risks of extemporaneously compounded therapeutic goods.

Report: Review of the need for further regulation of extemporaneous compounding <http://www.tga.gov.au/meds/extempcomp.htm>

Medicines committees update

Australian Drug Evaluation Committee (ADEC)

ADEC meeting dates for 2006 <http://www.tga.gov.au/docs/html/adec/adec.htm> and the 241st meeting recommendations (Aug 2005) <http://www.tga.gov.au/docs/html/adec/adec0241.htm> are available.

Adverse Drug Reactions Advisory Committee (ADRAC)

ADRAC meeting dates for 2006 <http://www.tga.gov.au/adr/adrac.htm#meet> are available.

Complementary Medicines Evaluation Committee (CMEC)

CMEC public recommendation summaries <http://www.tga.gov.au/docs/html/cmec/cmecminu.htm> for meetings 52 & 53 (Aug & Oct 2005) and extracted ratified minutes <http://www.tga.gov.au/docs/html/cmec/cmecminu.htm> for meetings 51 & 52 (Jun & Aug 2005) are available.

Australian Influenza Vaccine Committee (AIVC)

The Australian Influenza Vaccine Committee (AIVC) met on 6 October 2005 to review the influenza vaccine composition for the year 2006 influenza season. It agreed to adopt the September 2005 WHO recommendations.

The vaccine components should include:

• an A/New Caledonia/20/99 (H1N1)-like strain, 15 µg haemagglutinin (HA) per dose;
• an A/California/7/2004 (H3N2)-like strain, 15 µg haemagglutinin (HA) per dose;
• a B/Malaysia/2506/2004 (H1N1)-like strain, 15 µg haemagglutinin (HA) per dose

Details of the viruses recommended as suitable vaccine strains, and the reference standard reagents

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Orphan drugs

Orphan drug products are drugs, vaccines or in vivo diagnostic agents which physicians use to treat, prevent or diagnose rare diseases. The Australian Orphan Drug Program encourages sponsors to market orphan drugs in Australia by reducing costs through waiving fees.

Since the last issue of TGA News, 10 additions have been made to the list of drugs designated as orphan drugs. See: Drugs designated as orphan drugs <http://www.tga.gov.au/docs/html/orphand2.htm>

Overdosage advice

For many years the TGA has been concerned about the information contained in the Overdosage section of many Product Information (PI) documents and has encouraged sponsors to update these to reflect modern medical practice. In particular, recommendations to induce emesis or administer charcoal are not considered consistent with best practice management of overdosage, yet are often featured in the PI text.

A recent review by the Adverse Drug Reactions Advisory Committee (ADRAC) has highlighted that there are PIs that promote unacceptable management strategies.

The TGA wishes to emphasise that sponsors are responsible for ensuring that up-to-date and evidence-based information only is included in the PI document. Sponsors wishing to correct the Overdosage section of their PI to remove potentially dangerous and inaccurate information should consider lodging an SRN to do this.

As part of the program of ensuring records are up-to-date, the TGA will accept notifications of changes to the Overdosage section only and process them expeditiously until the end of June 2006.

After this time, it will be presumed that the sponsor fully supports the information in the PI and has data to support its advice for the management of overdosage should problems arise.

For more information see Prescription Medicines <http://www.tga.gov.au/pmeds/pmeds.htm>.

Phenylephrine

In view of the proposed rescheduling of pseudoephedrine, the TGA will adopt a modified approach to the registration of products that contain phenylephrine hydrochloride in place of pseudoephedrine. This will only apply to products that are intended to be marketed instead of or in parallel to equivalent registered products of the same sponsor that contain pseudoephedrine.

More information: Registration of products containing phenylephrine in place of pseudoephedrine <http://www.tga.gov.au/npmeds/phenylephrine.htm>

Price information code of practice

The National Co-ordinating Committee on Therapeutic Goods (NCCTG) has agreed that a Price Information Code of Practice (the Code) should be implemented. The Code will permit the publication of prices of medicines listed in Schedules 3, 4 and 8 of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) in Australia.

The final Regulation Impact Statement <http://www.tga.gov.au/medsd/rispicop.htm> includes a description of the comments received from stakeholders on the most appropriate regulatory mechanism for providing price information on prescription and some non-prescription medicines to consumers.

The Code will have legal underpinning which will allow pharmacists or dispensing doctors to provide consumers with price information about these medicines, on condition that it is provided in a way that complies with the Code.