National Health Act 1953 Determination under sections 85, 85A and 88 (No. PB 25 of 2006) (Cth)
COMMONWEALTH OF AUSTRALIA
National Health Act 1953
PHARMACEUTICAL BENEFITS
DETERMINATIONS UNDER SECTIONS 85, 85A AND 88
No. PB 25 of 2006
I, SUSAN LEIGH CAMPION, Acting Assistant Secretary, Pharmaceutical Benefits Branch, Department of Health and Ageing and Delegate of the Minister for Health and Ageing, pursuant to sections 85, 85A and 88 of the National Health Act 1953, hereby make the following Determinations:
1. These Determinations commence on 20 June 2006.
2. The Determinations (No. PB 24 of 2006) under sections 85, 85A and 88 of the National Health Act 1953 made on 22 May 2006 with effect from 1 June 2006 are, in these Determinations, referred to as the Principal Determinations.
3. The First Schedule — Part 1 to the Principal Determinations is amended by omitting the following details in respect of the pharmaceutical benefit Morphine Hydrochloride:
| Name of pharmaceutical benefit | Form (strength, type, size, etc.) | Manner of adminis-tration | Maxi-mum quantity | Maximum number of repeats | Brand | |
| Morphine Hydrochloride | Oral solution 2 mg per mL, 200 mL | Oral | 1 | .. | MF | |
| Oral solution 5 mg per mL, 200 mL | Oral | 1 | .. | MF | ||
| Oral solution 10 mg per mL, 200 mL | Oral | 1 | .. | MF | ||
and substituting:
| Name of pharmaceutical benefit | Form (strength, type, size, etc.) | Manner of adminis-tration | Maxi-mum quantity | Maximum number of repeats | Brand | |
| Morphine Hydrochloride | Oral solution 1 mg per mL, 500 mL | Oral | 1 | .. | VT | |
| Oral solution 2 mg per mL, 200 mL | Oral | 1 | .. | MF, PF | ||
| Oral solution 5 mg per mL, 200 mL | Oral | 1 | .. | MF, PF | ||
| Oral solution 5 mg per mL, 250 mL | Oral | 1 | .. | VT | ||
| Oral solution 5 mg per mL, 500 mL | Oral | 1 | .. | VT | ||
| Oral solution 10 mg per mL, 200 mL | Oral | 1 | .. | MF, PF | ||
| Oral solution 10 mg per mL, 250 mL | Oral | 1 | .. | VT | ||
4. The First Schedule — Part 2 to the Principal Determinations is amended by omitting the following details in respect of the pharmaceutical benefit Morphine Hydrochloride:
Name of pharmaceutical benefit: Morphine Hydrochloride
Form (strength, type, size, etc.): Oral solution 2 mg per mL, 200 mL
Purposes: In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
Manner of administration: Oral
Maximum quantity: 2
Maximum number of repeats: ..
Brand: MF
Name of pharmaceutical benefit: Morphine Hydrochloride
Form (strength, type, size, etc.): Oral solution 5 mg per mL, 200 mL
Purposes: In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
Manner of administration: Oral
Maximum quantity: 2
Maximum number of repeats: ..
Brand: MF
Name of pharmaceutical benefit: Morphine Hydrochloride
Form (strength, type, size, etc.): Oral solution 10 mg per mL, 200 mL
Purposes: In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
Manner of administration: Oral
Maximum quantity: 2
Maximum number of repeats: ..
Brand: MF
and substituting:
Name of pharmaceutical benefit: Morphine Hydrochloride
Form (strength, type, size, etc.): Oral solution 1 mg per mL, 500 mL
Purposes: In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
Manner of administration: Oral
Maximum quantity: 2
Maximum number of repeats: ..
Brand: VT
Name of pharmaceutical benefit: Morphine Hydrochloride
Form (strength, type, size, etc.): Oral solution 2 mg per mL, 200 mL
Purposes: In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
Manner of administration: Oral
Maximum quantity: 2
Maximum number of repeats: ..
Brand: MF, PF
Name of pharmaceutical benefit: Morphine Hydrochloride
Form (strength, type, size, etc.): Oral solution 5 mg per mL, 200 mL
Purposes: In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
Manner of administration: Oral
Maximum quantity: 2
Maximum number of repeats: ..
Brand: MF, PF
Name of pharmaceutical benefit: Morphine Hydrochloride
Form (strength, type, size, etc.): Oral solution 5 mg per mL, 250 mL
Purposes: In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
Manner of administration: Oral
Maximum quantity: 2
Maximum number of repeats: ..
Brand: VT
Name of pharmaceutical benefit: Morphine Hydrochloride
Form (strength, type, size, etc.): Oral solution 5 mg per mL, 500 mL
Purposes: In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
Manner of administration: Oral
Maximum quantity: 2
Maximum number of repeats: ..
Brand: VT
Name of pharmaceutical benefit: Morphine Hydrochloride
Form (strength, type, size, etc.): Oral solution 10 mg per mL, 200 mL
Purposes: In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
Manner of administration: Oral
Maximum quantity: 2
Maximum number of repeats: ..
Brand: MF, PF
Name of pharmaceutical benefit: Morphine Hydrochloride
Form (strength, type, size, etc.): Oral solution 10 mg per mL, 250 mL
Purposes: In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
Manner of administration: Oral
Maximum quantity: 2
Maximum number of repeats: ..
Brand: VT
5. The Third Schedule — Part 1 to the Principal Determinations is amended by omitting the following details in respect of the pharmaceutical benefit Morphine Hydrochloride:
| Name of pharmaceutical benefit | Form (strength, type, size, etc.) | Manner of adminis-tration | Maxi-mum quantity | Maximum number of repeats | Brand | |
| Morphine Hydrochloride | Oral solution 2 mg per mL, 200 mL | Oral | 1 | .. | MF | |
| Oral solution 5 mg per mL, 200 mL | Oral | 1 | .. | MF | ||
| Oral solution 10 mg per mL, 200 mL | Oral | 1 | .. | MF | ||
and substituting:
| Name of pharmaceutical benefit | Form (strength, type, size, etc.) | Manner of adminis-tration | Maxi-mum quantity | Maximum number of repeats | Brand | |
| Morphine Hydrochloride | Oral solution 1 mg per mL, 500 mL | Oral | 1 | .. | VT | |
| Oral solution 2 mg per mL, 200 mL | Oral | 1 | .. | MF, PF | ||
| Oral solution 5 mg per mL, 200 mL | Oral | 1 | .. | MF, PF | ||
| Oral solution 5 mg per mL, 250 mL | Oral | 1 | .. | VT | ||
| Oral solution 5 mg per mL, 500 mL | Oral | 1 | .. | VT | ||
| Oral solution 10 mg per mL, 200 mL | Oral | 1 | .. | MF, PF | ||
| Oral solution 10 mg per mL, 250 mL | Oral | 1 | .. | VT | ||
Dated this 19th day of June 2006.
SUSAN LEIGH CAMPION
Acting Assistant Secretary
Pharmaceutical Benefits Branch
Department of Health and Ageing
Delegate of the Minister for Health and Ageing
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