EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2009 (No. 4)
Sodium bicarbonate for oral rehydration therapy
Section 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2009 (No. 4) (the Listing Notice) is a Notice made by the delegate of the Minister for Health and Ageing under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act).
The Listing Notice has the effect of permitting the use of sodium bicarbonate as an active ingredient in Listed medicines for oral rehydration therapy (ORT) subject to specified conditions.
The Listing Notice commenced on the day after it was registered on the Federal Register of Legislative Instruments (FRLI).
BACKGROUND
The Act provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.
Unless specifically exempted or authorised under the Act, therapeutic goods are required to be included in the Australian Register of Therapeutic Goods (the ARTG) before being supplied in, imported into, manufactured in or exported from Australia (sections 19B and 19D of the Act). Medicines are registered or listed in the ARTG, depending on the ingredients they contain and the therapeutic claims that are being made.
In general, products that contain low risk ingredients are referred to as listed medicines in Australia. Most listed medicines are considered to be of relatively low risk compared to other types of medicines, such as prescription and over-the-counter medicines, as they may only contain ingredients that have been approved by the TGA as being of low risk and may only make limited therapeutic claims.
Schedule 4 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out those therapeutic goods that are required to be included in the part of the ARTG for listed medicines. At present, Schedule 4 of the Regulations does not include reference to sodium bicarbonate as an active ingredient for oral medicines.
In order to facilitate the timely approval of new listable therapeutic goods, subsection 9A(5) of the Act allows the Minister for Health and Ageing to publish a listing notice that has the effect of permitting the use of particular therapeutic goods in listed medicines subject to any specified conditions.
Pursuant to subsection 9A(6) of the Act, if Schedule 4 of the Regulations is amended to include reference to a substance that has been the subject of a listing notice, that listing notice ceases to have effect.
Sodium bicarbonate for oral rehydration therapy
The TGA has reviewed a request for approval of sodium bicarbonate (NaHCO3) for use as an active ingredient in Listed medicines, in particular in ORTs. Sodium bicarbonate is currently only permitted for use as an excipient in Listed medicines.
There are no safety concerns about a typical use of sodium bicarbonate as an excipient in medicines, as the salt is generally considered to be non-toxic and non-irritant. However, there are reports that excessive amounts of the salt may disturb the body’s electrolyte balance (causing metabolic alkalosis) and possibly result in sodium overload. Importantly, a large intake of sodium has been sufficient to exacerbate chronic heart failure in susceptible individuals.
Under current TGA labelling requirements for Listed medicines, the sodium content of a product must be stated on the product label along with the advice on its contribution to the maximum recommended daily intake of sodium. This regulatory measure has been designed to effectively address the safety concerns associate with the excessive intake of sodium.
The Delegate of the Minister for Health and Ageing has signed a listing notice that sodium bicarbonate be approved for use as an active ingredient in Listed medicines for oral rehydration therapy, subject to the following conditions:
- the formulation complies with the requirements specified in the British Pharmacopoeia monograph for Oral Rehydration Salts;
- the sodium, potassium and glucose content, and total osmolarity of the solution after it has been prepared according to the instructions on the packet are consistent with the following criteria, as specified by the World Health Organization (WHO) and the United Nations Children’s Fund (UNICEF) in the document, ‘Expert consultation on oral rehydration salts formulation, 18 July 2001’.
COMPONENT | CONCENTRATION |
Sodium | 60 – 90 mEq/l |
Glucose | At least equal that of sodium and less than 111 mmol/l |
Potassium | 15 – 25 mEq/l |
Total Osmolarity | 200 - 310 |
- the product label includes the following advisory statements:
- “Use only as directed”, and
- “If diarrhoea persists, seek medical advice”; and
- the product label includes a description of the symptoms of dehydration for the benefit of consumers;
- the proposed directions for use must be clearly outlined on the label; and
- when indicated for use in children, the directions for use on the product label includes the following additional directions:
Age of child | Additional Directions |
Under 6 months | Medical advice should be sought if diarrhoea persists for more than 6 hours. |
Under 3 years | Medical advice should be sought if diarrhoea persists for more than 12 hours. |
3-6 years | Medical advice should be sought if diarrhoea persists for more than 24 hours. |
Over 6 years | Medical advice should be sought if diarrhoea persists for more than 48 hours. |
CONSULTATION
As there are no safety concerns associated with extending the availability of sodium bicarbonate from an excipient only to an active ingredient in Listed medicines for oral use, the Complementary Medicines Evaluation Committee was not consulted. The listing of sodium bicarbonate as an active ingredient in Listed medicines for oral use is minor and machinery in nature.