Therapeutic Goods (Listing) Notice 2009 (No. 3)

EXPLANATORY STATEMENT

THERAPEUTIC GOODS (LISTING) NOTICE 2009 (No. 3)

Potassium chloride for oral rehydration therapy

Section 9A(5), Therapeutic Goods Act 1989

OUTLINE

Therapeutic Goods (Listing) Notice 2009 (No. 3) (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 potassium chloride 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 potassium chloride as an active ingredient for use in Listed medicines for ORT.

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.

Potassium chloride for oral rehydration therapy

Potassium chloride is currently only permitted for use as an active ingredient in Listed medicines intended for dental use, provided the total potassium content in the product does not exceed an amount equivalent to a 3.75% concentration of potassium chloride, which restricts the potassium ion in the product to 20 g/kg.  When used as an excipient or component in Listed medicines, the concentration of potassium chloride must not exceed 550 mg per daily dosage unit.

Potassium is widely available and a typical daily dietary intake is approximately 4 g.  Potassium plays an important role in nerve function.  Dehydration may result in lowered potassium and hence, potassium salts are often included in ORTs to correct this deficit.

Adverse reactions relating to use of ORTs containing potassium chloride are uncommon.  However, inadvertent misuse of products containing potassium has the potential to be associated with significant adverse events.  Excess administration of potassium may cause hyperkalaemia, which may in turn disrupt neural conduction resulting in cardiac arrhythmias and cardiac arrest.  Individuals with renal impairment are at particular risk of developing hyperkalaemia.

The Complementary Medicines Evaluation Committee (CMEC) considered the application for this substance at its 71st meeting in March 2009.  The CMEC recommended approval of KCl for use in listed medicines for oral rehydration therapy, where consistent with the British Pharmacopoeia (BP) monograph for oral rehydration salts and subject to appropriate label requirements.  The CMEC also recommended that the content of KCl in Listed medicines should be limited to 550 mg per dose unit.

The Delegate of the Minister for Health and Ageing has signed a listing notice that potassium chloride be approved for use as an active ingredient in Listed medicines for ORT, 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’.

• the content of potassium chloride must not exceed 550 mg per dosage unit;
• the product label includes the following advisory statements:

-            “Contains potassium. If you have kidney disease or are taking heart or blood pressure medicines – consult your doctor or pharmacist before use. Keep out of reach of children”,

-            “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:

CONSULTATION

Although the listing of potassium chloride as an active ingredient in Listed medicines for oral rehydration therapy is minor and machinery in nature, the CMEC was consulted during the approval process for this ingredient.