New listable substances approved by CMEC

The new Complementary Medicines Evaluation Committee (CMEC) is meeting regularly in 1998 to provide advice to the TGA on the evaluation of the safety of new complementary medicine substances and on postmarket reviews of certain products. The membership covers areas of expertise in nutrition, toxicology, complementary medicines practice, mainstream medical practice, regulatory affairs, consumer interests and poisons regulation.

At its first meeting, held December 1997, the CMEC reviewed the safety of royal jelly and has made some recommendations for new provisions for the listing of royal jelly products. These provisions are aimed at allowing consumers to make an informed choice by providing information on possible adverse effects, particularly for the most susceptible individuals (asthmatics, allergy sufferers and children), from using royal jelly. Royal jelly has been recommended for inclusion as an active ingredient in listable products (previously it was only permitted as an excipient).

The CMEC recognised that consistency in the quality of royal jelly sold in Australia needs greater control and the TGA has obtained agreement from the Nutritional Foods Association of Australia to develop a royal jelly standard for therapeutic goods. The CMEC has also recommended that royal jelly presented in capsules, phials and powders be declared to be therapeutic goods.

This proposal will be open for public discussion after further discussion with industry representatives.

From the first three meetings held, three new substances have been recommended for inclusion in Part 5 of Schedule 4 to the Regulations, meaning that these substances have been assessed as low risk and will be permitted in listable products supplied in Australia. These substances include two actives and one excipient. Further details will be available once communication with sponsors is complete on these matters.

Two herbs have been identified as priorities for review from information obtained from individuals and the Adverse Drug Reaction database. The review of the safety of ginger is continuing and a safety review of echinacea has recently commenced. Further priorities are being established by a CMEC working party especially convened for that purpose.

Public consultation forms an important part of CMEC work where matters are not confidential. Invitations to comment are sent to industry associations and other relevant stakeholders, including those who have asked to be placed on the mailing list. A comment period (usually six weeks) is allowed after which the Complementary Medicines Section evaluates the submissions. Comments are incorporated into a report for CMEC's consideration at the next available meeting. Outcomes are made public through the same circulation list and TGA News.

Changes to advertising of pharmacist-only (Schedule 3) medicines

The Hon. Trish Worth, MP, Parliamentary Secretary to the Minister for Health and Family Services, Dr. Michael Wooldridge, recently announced that advertising of pharmacist-only supplied medicines was permitted. Until now, no pharmacist-only products could be advertised using a brand name except to health professionals, for example through specialist medical journals.

What are pharmacist-only (schedule 3) medicines?

Pharmacist-only medicines include treatments for common conditions such as antifungals, antihistamines and smoking cessation products which patients can safely self-administer with advice from health professionals. Substances contained in these products are listed in Schedule 3 of the Standard for the Uniform Scheduling of Drugs and Poisons by the National Drugs and Poisons Scheduling Committee (NDPSC).

What do the recent changes in advertising regulations mean?

Following the general review of therapeutic goods administration in 1996/97, a specific review of brand advertising of scheduled pharmacist-only medicines was undertaken by the TGA (in consultation with industry, health care professionals and consumer organisations).

The brand advertising review recommended that advertising of pharmacist-only medicines should be allowed, subject to safeguards and approval by the NDPSC. Following endorsement from all State and Territory Health Ministers, Ms Worth accepted the recommendation.

She said that "advertising of certain medications will make patients more aware of available treatments while promoting the sensible use of medications".

The National Co-ordinating Committee of Therapeutic Goods (NCCTG) will develop guidelines for deciding which Schedule 3 products may be advertised while the NDPSC will assess the appropriateness of Schedule 3 substances for advertising. Advertisements must comply with the Therapeutic Goods Advertising Code (TGAC).

Comments on the advertising changes:

Mr Stephen Greenwood, Executive Director of the Pharmacy Guild of Australia, declared them "sensible and practical".

Mr Kevin Darke, President of the Proprietary Medicines Association of Australia, and Business Development Director for SmithKline Beecham Pharmaceuticals said that "the industry welcomes this significant change" which "builds supportive relationships between all sectors of the Australian health care system".

Mr Tony Nunan, President of the Pharmaceutical Society of Australia, said the Society will be "taking a campaign to our pharmacists to make them realise the importance of this decision and their responsibilities of this decision, both in giving out the correct product for the correct ailment and referring to GPs where necessary."

"This is an example of sensible negotiation and regulation"
"...an example of trust. I would like to thank you all for the
spirit of co-operation that has taken place in advancing the issues
in the public health interests of all Australians".