National Health (Pharmaceutical Benefits) Regulations (Amendment)

Administered by Department of Health, Disability and Ageing

Legislation au F1996B02866 Regulations Not in force Legislative Instrument

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STATUTORY RULES

1968 No

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REGULATIONS UNDER THE NATIONAL HEALTH ACT 1953-1967.

I, THE GOVERNOR-GENERAL in and over the Commonwealth of Australia, acting with the advice of the Federal Executive Council, hereby make the following Regulations under the National Health Act 1953-1967.

Dated this twenty-fourth day of July, 1968.

CASEY

Governor-General.

By His Excellency’s Command,

(SGD.) A. J. FORBES

Minister of State for Health.

________

 

Amendments of the National Health (Pharmaceutical Benefits) Regulations†

Commencement.

1. These Regulations shall come into operation on the first day of August, 1968.

First Schedule.

2.—(1.) The First Schedule to the National Health (Pharmaceutical Benefits) Regulations is amended by omitting items 66, 79, 98, 182, 400, 416 and 417.

(2.) The First Schedule to the National Health (Pharmaceutical Benefits) Regulations is amended—

(a) by inserting after item 235 the following item:—

“ 235a. Methicillin Sodium ”; and

(b) by inserting after item 316 the following item:—

“ 316a. Prednisolone Trimethylacetate Injection ”.

Second Schedule.

3.—(1.) The Second Schedule to the National Health (Pharmaceutical Benefits) Regulations is amended by inserting after item 33 the following items:—

“ 33a

Dexamethasone......................

Dexamethasone with Framycetin Sulphate and Gramicidin

33b

Dexamethasone Metasulphobenzoate

Dexamethasone Metasulphobenzoate with Framycetin Sulphate and Gramicidin”.

(2.) The Second Schedule to the National Health (Pharmaceutical Benefits) Regulations is amended by omitting item 63 and inserting in its stead the following item:—

“ 63

Hexachlorophane, B.P..................

Hexachlorophane B.P. with Entsufon

 

 

Hexachlorophane B.P. with Terric

 

 

Hexachlorophane B.P. in Soap Solution

 

 

Hexachlorophane B.P. with Chloroxylenol ”.

Third Schedule.

4. The Third Schedule to the National Health (Pharmaceutical Benefits) Regulations is amended as set out in the First Schedule to these Regulations.

Fifth Schedule.

5. The Fifth Schedule to the National Health (Pharmaceutical Benefits) Regulations is amended as set out in the Second Schedule to these Regulations.

_______________________________________________________________________________________

Notified in the Commonwealth Gazette on                                                                                 1968.

† Statutory Rules 1960, No. 17 as amended to date. For previous amendments of the National Health (Pharmaceutical Benefits) Regulations, see footnote to Statutory Rules 1968, No. 44, and see also Statutory Rules 1968, No. 44.

18279/68—PRICE 10c          10/12.7.1968


THE SCHEDULES

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Regulation 4.

FIRST SCHEDULE

Amendments of the Third Schedule to the National Health (Pharmaceutical Benefits) Regulations

1. Omit item 1, insert:—

“1. Acepifylline”

1a. Acetazolamide Sodium”.

2. After item 14 insert:—

“14a. Aloxiprin”.

3. After item 85 insert:—

85a. Chloroxylenol”.

4. After item 94 insert:—

94a. Coal Tar Solution Strong B.P.C.”.

5. After item 105 insert:—

105a. Debrisoquine”.

6. After item 109 insert:—

109a. Dexamethasone Metasulphobenzoate”.

7. After item 137 insert:—

137a. Ethchlorvynol”.

8. After item 168a insert:—

168b. Haloperidol”.

9. After item 241 insert:—

“241a. Nitrazepam”.

10. After item 250 insert:—

“250a. Orphenadrine Citrate”.

11. After item 255 insert:—

255a. Oxymetholone”.

12. Omit from item 299 “Hemisuccinate”, insert “Succinate”.

13. After item 304 insert:—

304a. Protriptyline Hydrochloride”.

14. Omit item 367.

15. After item 373 insert:—

373a. Tiemonium Iodide”.

16. After item 379 insert:—

379a. Triacetyloleandomycin”.

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SECOND SCHEDULE      Regulation 5.

Amendments of the Fifth Schedule to the National Health (Pharmaceutical Benefits) Regulations

1 After item 5 insert:—

5a

Aloxiprin

Any disease or condition in a pensioner”.

2. Omit from item 6 “ (2) Amino Acids ” (in the second column).

3. Omit item 10, insert:—

10

(1) Ampicillin Capsules, B.P.......

With the written authority of the Director-General—

Gram-negative infections in pregnant women

Infections in children, in which penicillin and sulphonamides are not effective

Infections where positive bacteriological evidence confirms that ampicillin is an appropriate therapeutic agent and the Director-General is satisfied that it is the most appropriate therapeutic agent in all the circumstances of the case

Acute infections threatening the life of a patient where clinical evidence shows that ampicillin is an appropriate therapeutic agent and the Director-General is satisfied that it is the most appropriate therapeutic agent in all the circumstances of the case

Chronic bronchitis complicated by emphysema where other therapeutic agents have failed ”.

 

(2) Ampicillin Injections, Tablets and Suspension

 

 


SECOND SCHEDULE—continued

4. Insert in item 16, after “ Prednisolone Tablets ” (in the third column), “, B.P.”.

5. Omit item 22.

6. Insert in item 29, after “ Capsule ” (in the third column), “, B.P.”.

7. Insert in item 33, after “ Capsules ” (in the third column), “, B.P.”.

8. Item 38.—

(a) insert before “ Hypsarrhythmia ” (in the third column)—

“ Acute exacerbations of multiple sclerosis

Acute phase of Bell’s palsy ”; and

(b) insert after “Cortisone Injection” (in the third column), “, B.P.”.

9. Omit items 40 to 43 (inclusive), insert:—

“ 40

Cortisone Tablets, B.P.......

With the written authority of the Director-General, a disease or condition specified in this column in relation to Cortisone Injection, B.P.

“ 41

Cyanocobalamin Injection, B.P.

Established megalocytic anaemia

Neuroblastoma

Sub-acute combined degeneration of the cord Treatment in post-gastrectomy

41a

Cymogran...............

With the written authority of the Director-General, phenylketonuria

“ 42

(1) Cycloserine Tablets, B.P...

Any disease or condition in a patient receiving treatment in or at an approved hospital

 

(2) Cycloserine Capsules, B.P..

“ 42a

(1) Demethylchlortetracycline Capsules, B.P.

A disease or condition specified in this column in relation to Chlortetracycline Capsules B.P., except herpes zoster opthalmicus

 

 

(2) Demethylchlortetracycline Hydrochloride Oral Paediatric Drops and Oral Suspension

 

 

 

“ 43

Demethylchlortetracycline Hydrochloride with Nystatin

Any disease or condition specified in this column in relation to Oxytetracycline Hydrochloride with a buffering agent and Nystatin ”.

10. Insert in item 47, after “ Prednisolone Tablets ” (in the third column), “, B.P.”.

11. After item 57 insert:—

57a

Dimethicone Creams.........

Use with surgical appliances ”.

12. Insert in item 60, after “ Capsules ” (in the third column), “, B.P.”.

13. After item 80 insert:—

80a

Haloperidol.............

Any disease or condition in a pensioner

Any disease or condition in a patient receiving treatment in or at an approved hospital

With the written authority of the Director-General—

Radiation sickness

Huntington’s chorea

Late-stage malignancy

The treatment of a mental disorder in a person who has been discharged from an approved hospital at which ho received treatment for a mental disorder and who is living in a place remote from an approved hospital

The treatment of a mental disorder in a person who has, after treatment for a mental disorder, been discharged from an approved hospital if a medical officer of the hospital gives a certificate certifying that the person received treatment at that hospital and may require further treatment with Haloperidol ”.


SECOND SCHEDULE—continued

14. Omit item 82, insert:—

“ 82

(1) Hexachlorophane with Chloroxylenol

Any disease or condition in patient receiving treatment in or at an approved hospital ”.

 

(2) Hexachlorophane with Entsufon

 

 

(3) Hexachlorophane with Lissapol

 

 

(4) Hexachlorophane in Soap Solution

 

15. Insert in item 83, after “ Injection ” (in the third column), “, B.P.”.

16. Omit from item 96 “ Myxoedema coma ” (in the third column).

17. Omit from item 99 “ Endometrial carcinoma ” (in the third column), insert “ Adenocarcinoma of the uterus (endometrial carcinoma) ”.

18. Omit item 100, insert:—

“ 100

Medroxyprogesterone Acetate Tablets 100 mg.

Adenocarcinoma of the body of the uterus Hypernephroma

100a

Medroxyprogesterone Acetate Injections

Adenocarcinoma of the uterus (endometrial carcinoma)

Hypernephroma

Progesterone deficiency proven by hormonal assay of lateral wall smear ”.

 

 

 

 

 

19. Insert in item 104, after “ Capsules ” (in the third column), “, B.P.”.

20. Omit item 106, insert:—

“ 106

Methicillin Injection, B.P.......

Proven or suspected staphylococcal septicaemia ”

 

21. Omit from item 114 “ With the written authority of the Director-General, urinary tract infections ” (in the third column), insert “ Urinary tract infections in which sulphonamides are not effective ”.

22. After item 116 insert:—

116a

Natamycin................

Monilia infections ”.

 

23. After item 120 insert:—

120a

Nitrazepam...............

Myoclonic epilepsy in children ”.

 

24. Omit from item 126 “(2) Orciprenaline Sulphate Solution for Inhalation” (in the second column).

25. After item 128 insert;—

“ 128a

Oxymetholone.............

With the written authority of the Director-General—

Aplastic anaemia

Primary refractory anaemias ”.

26. Insert in item 129, after “ Capsules ” (in the third column), “, B.P.”.

27. Insert in item 130, after “ Capsules ” (in the third column), “, B.P.”.

28. Omit item 135, insert:—

“ 135

Paramethasone Acetate ..

With the written authority of the Director-General—

Acute phase of herpes zoster

A disease or condition specified in this column in relation to Cortisone Injection, B.P.”.


SECOND SCHEDULE—continued

29. After item 143 insert:—

143a

(1) Phenylbutazone Suppositories

(2) Phenylbutazone Injection........

For the treatment of the following conditions in persons who cannot tolerate Phenylbutazone Tablets, B.P. and Phenylbutazone Capsules:—

Acute attacks of gout

Ankylosing spondylitis

Psoriatic arthritis

Reiter’s syndrome

Rheumatoid arthritis or osteoarthritis not responding to salicylates ”.

 

 

 

 

30. Omit item 149, insert:—

149

Prednisolone Tablets, B.P. ..

With the written authority of the Director-General—

Acute exophthalmic ophthalmoplegia

Acute heart block complicating myocardial Infarction

Acute phase of herpes zoster

Benign intracranial hypertension

Cerebral oedema

Cerebral tumors

Encephalitis

Interstitial keratitis due to syphilis or vernal conjunctivitis

Malignancy treatment in conjunction with radiotherapy or chemotherapy

Malignant exophthalmos

Meningitis

Nodular non-suppurative panniculitis (Christian-Weber disease)

Oedema of the spinal cord following trauma or infection

A disease or condition specified in this column in relation to Cortisone Injection, B.P. except total adrenalectomy, Addison’s disease or adrenocortical hypoplasia ”.

 

 

 

 

 

 

 

 

31. Omit item 150, insert:—

“ 150

Prednisolone Methyl Acetate Injection

Intra-articular use  ”.

32. Omit item 151, insert:—

“ 151

(1) Prednisolone Acetate Injection

(2) Prednisolone Tertiary Butyl

Acetate Injection

Intra-articular use ”.

 

33. Omit from item 153 “ Hemisuccinate ” (in the second column), insert “ Succinate ”.

34. Insert in item 154, after “ Tablets ” (in the third column), “ B.P.”.

35. Omit from item 157 “ (2) Pyrazinamide ” (in the second column).

36. After item 157 insert:—

157a

Protriptyline Hydrochloride ..

Any disease or condition in a pensioner

Any disease or condition in a patient receiving treatment in or at an approved hospital

With the written authority of the Director-General—

The treatment of a mental disorder in a person who has been discharged from an approved hospital at which he received treatment for a mental disorder and who is living in a place remote from an approved hospital

The treatment of a mental disorder in a person who has, after treatment for a mental disorder, been discharged from an approved hospital if a medical officer of the hospital gives a certificate certifying that that person received treatment at the hospital and may require further treatment with Protriptyline Hydrochloride

 

 

“ 157b

Pyrazinamide .. ..

Any disease or condition in a patient receiving treatment in or at an approved hospital ”.


SECOND SCHEDULE—continued

37. Omit from item 177 “ Patients known to be sensitive to horse serum ” (in the third column), insert “ Patients who have previously received an injection of equine serum ”.

38. Insert in item 180, after “ Capsules ” (in the third column), “, B.P.”.

39. Omit from item 184:—

“ Thioridazine

Thioridazine Hydrochloride ”

(in the third column), insert—

“ Thioridazine

Thioridazine Tablets, B.P.”.

40. After item 188 insert:—

“ 188a

Triacetyloleandomycin........

Brucellosis

Intestinal amoebiasis

Leptospirosis

Lymphogranuloma venereum

Mycoplasma pneumoniae (Eaton’s Agent)

Psittacosis

Rickettsial infections

Staphylococcal septicaemia or staphylococcal pneumonia

Any bacterial infections or spirochaetal infection or actinomycosis or trachoma where these cannot be treated safely and effectively by sulphonamides or penicillins

Pre-operative and post-operative therapy where there are reasonable grounds for believing that infection may occur ”.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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By Authority: A. J. Arthur, Commonwealth Government Printer, Canberra

Overview

The Statutory Rules 1968 No. ______, made under the National Health Act 1953-1967, amend the National Health (Pharmaceutical Benefits) Regulations to update the list of pharmaceutical substances eligible for benefits. These regulations were introduced to address the need for an updated and comprehensive list of pharmaceutical benefits provided under the national health scheme, ensuring that the latest and most effective medications are accessible to the public. Enacted by the Governor-General in the Federal Executive Council, these amendments aim to align the regulations with current medical practices and advancements in pharmaceutical science, thereby enhancing the overall health outcomes for Australians. The policy objective is to provide access to necessary medications while maintaining the financial sustainability of the national health scheme.

Scope and Application

The Statutory Rules 1968 No.______, made under the National Health Act 1953-1967, primarily serve to amend the National Health (Pharmaceutical Benefits) Regulations, which are concerned with the provision of pharmaceutical benefits in Australia. These Regulations apply to the Australian population, ensuring that eligible individuals have access to certain medications under the Pharmaceutical Benefits Scheme (PBS). The Regulations are effective from the first day of August, 1968, and involve amendments to several schedules that list specific medications and their approved uses. For example, the Regulations introduce new medications such as Methicillin Sodium and Prednisolone Trimethylacetate Injection into the First Schedule and revise the list of approved uses for existing medications in the Fifth Schedule. The Regulations also clarify and expand the conditions under which certain medications can be prescribed and funded under the PBS, such as updating the conditions for the prescription of Ampicillin and adding new conditions for the use of Haloperidol. These amendments aim to enhance the scope of pharmaceutical benefits available to the public, thereby improving access to essential medications.

Key Provisions

The Regulations, which come into effect on 1 August 1968, amend the National Health (Pharmaceutical Benefits) Regulations under the National Health Act 1953-1967. The primary amendments include the addition and removal of certain pharmaceutical items from the schedules, impacting the list of drugs eligible for subsidy or benefits under the National Health scheme. For instance, new items such as Methicillin Sodium and Prednisolone Trimethylacetate Injection have been added to the First Schedule, while others like Hexachlorophane have been modified with new formulations or combinations. Additionally, the Second Schedule has been updated with new items and revised indications for existing drugs, reflecting changes in therapeutic practices or responses to emerging health needs. These Regulations impose specific obligations on healthcare providers, pharmaceutical manufacturers, and the government. Healthcare providers must comply with the updated listings in the schedules when prescribing or supplying drugs that are now eligible for benefits or have changed in their eligibility. Pharmaceutical manufacturers need to ensure their products align with the new regulatory requirements, such as the formulation or combination changes noted in the schedules. The government, through the Minister for Health, has the responsibility to administer and enforce these Regulations, ensuring that the National Health scheme operates effectively and efficiently. Breaches of these Regulations may lead to various consequences depending on the nature and severity of the violation. While the specific penalties for non-compliance are not detailed in the provided text, under the broader legislative framework, penalties can range from fines to more severe sanctions, including imprisonment for serious or repeated offences. The exact penalties would be determined based on the specific provision breached and the circumstances of the breach, as outlined in the parent Act or other related legislation.

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