Statutory Rules of Northern Ireland

2004 No. 142

HEALTH AND PERSONAL SOCIAL SERVICES

Health and Personal Social Services (General Medical Services Contracts) (Prescription of Drugs Etc) Regulations (Northern Ireland) 2004

Made

29th March 2004

Coming into operation

1st April 2004

The Department of Health, Social Services and Public Safety(1), in exercise of the powers conferred on it by Articles 57D and 106(b) of the Health and Personal Social Services (Northern Ireland) Order 1972(2), and of all other powers enabling it in that behalf, hereby makes the following Regulations:

Citation and commencementN.I.

1.  These Regulations may be cited as the Health and Personal Social Services (General Medical Services Contracts) (Prescription of Drugs Etc) Regulations (Northern Ireland) 2004 and shall come into operation on 1st April 2004.

Commencement Information

I1Reg. 1 in operation at 1.4.2004, see reg. 1

Drugs, medicines and other substances that may not be orderedN.I.

2.  A drug, medicine and other substance listed in Schedule 1 may not be ordered for a patient in the provision of medical services under a general medical services contract.

Commencement Information

I2Reg. 2 in operation at 1.4.2004, see reg. 1

Drugs, medicines and other substances that may be ordered only in certain circumstancesN.I.

3.  A drug, medicine or other substance specified in an entry in column 1 of Schedule 2 may not be ordered for a patient in the provision of medical services under a general medical services contract unless –

(a)that patient is a person of a description mentioned in column 2 of that entry; and

(b)that drug, medicine or other substance is prescribed for that patient only for the purpose specified in column 3 of that entry.

Commencement Information

I3Reg. 3 in operation at 1.4.2004, see reg. 1

Sealed with the Official Seal of the Department of Health, Social Services and Public Safety on 29th March 2004.

L.S.

James F. Livingstone

Senior Officer of the

Department of Health, Social Services and Public Safety

Sealed with the Official Seal of the Department of Finance and Personnel on 29th March 2004.

L.S.

C. Doran

Senior Officer of the

Department of Finance and Personnel

Regulation 2

SCHEDULE 1N.I.DRUGS, MEDICINES AND OTHER SUBSTANCES NOT TO BE ORDERED UNDER A GENERAL MEDICAL SERVICES CONTRACT

Commencement Information

I4Sch. 1 in operation at 1.4.2004, see reg. 1

Regulation 3

[F1SCHEDULE 2N.I.DRUGS, MEDICINES AND OTHER SUBSTANCES TO BE ORDERED ONLY IN CERTAIN CIRCUMSTANCES

Textual Amendments

Column 1

Drug

Column 2

Patient

Column 3

Condition

In this Schedule—

“at clinical risk” means in relation to a patient, a patient who—

(a)

has chronic respiratory disease;

(b)

has asthma that requires continuous or repeated use of inhaled or systemic steroids or with previous exacerbations requiring hospital admission;

(c)

has chronic heart disease;

(d)

has chronic renal failure;

(e)

has chronic liver disease;

(f)

has chronic neurological disease;

(g)

has diabetes; or

(h)

is immunosuppressed;

“EEA Agreement” means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992 as adjusted by the Protocol signed at Brussels on 17th March 1993;

“EEA State” means a State which is a contracting party to the EEA Agreement;

“general medical practitioner” has the same meaning as in the Health and Personal Social Services (General Medical Services Contracts) Regulations (Northern Ireland) 2004;

“patient” has the same meaning as in the Health and Personal Social Services (General Medical Services Contracts) Regulations (Northern Ireland) 2004;

“residential care home” and “nursing home” have the same meaning as in the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003.]

ClobazamAny patientTreatment of epilepsy
F2. . .F2. . .F2. . .

Niferex Elixir 30ml

Paediatric Dropper Bottle

Infants born prematurely

Prophylaxis and treatment of iron deficiency

Nizoral CreamAny patient

Treatment of seborrhoeic dermatitis and pityriasis versicolor

[F3The following drugs—]

  • F4...

  • F4...

  • F4...

  • Sildenafil (Viagra)

  • Tadalafil F4...

  • F4...

  • Vardenafil F4...

[F5(1) The following patients with erectile dysfunction—]

(a)

Any man with erectile dysfunction who on 14th September 1998 was receiving a course of treatment under the Order, the National Health Service Act 1977, or the National Health Service (Scotland) Act 1978 for this condition with any of the following drugs –

  • Alprostadil (Caverject), (Muse), (Viridial)

  • Apmorphine hydrochloride (Uprima)

  • Moxisylyte Hydrochloride (Uprima)

  • Moxisylyte Hydrochloride (Erencos)

  • Sildenafil (Viagra)

  • Tadalafil (Cialis) Thymoxamine

  • Hydrochloride (Erecnos) Vardenafil (Levitra); or

(b)

[F6a man who is a national of an EEA State who—

(i)

immediately before IP completion day was entitled to treatment by virtue of Article 7(2) of Council Regulation 1612/68 as extended by the EEA Agreement or was entitled to treatment by virtue of any other enforceable EU right;

(ii)

has erectile dysfunction and was on 14th September 1998 receiving a course of treatment under a national health insurance system of an EEA State for that condition with any of the drugs listed in sub-paragraph (a); and

(iii)

immediately before IP completion day was receiving a course of treatment for the condition mentioned in paragraph (ii) of this sub-paragraph with any of the drugs listed in sub-paragraph (a); or]

(c)

[F7a man who is not a national of an EEA State but who is the member of the family of such a national and who—

(i)

immediately before IP completion day had an enforceable EU right to be treated no less favourably than the national in the provision of medical treatment;

(ii)

has erectile dysfunction and was on 14th September 1998 receiving a course of treatment for that condition with any of the drugs listed in sub-paragraph (a); and

(iii)

immediately before IP completion day was receiving a course of treatment for the condition mentioned in paragraph (ii) of this sub-paragraph with any of the drugs listed in sub-paragraph (a); or]

(d)

a man who is suffering from any of the following –diabetes, multiple sclerosis, Parkinson’s disease, poliomyelitis, prostate cancer, severe pelvic injury, single gene neurological disease, spina bifida, spinal cord injury; or

(e)

a man who is receiving treatment for renal failure by dialysis; or

(f)

a man who has had the following surgery–prostatectomy; radical pelvic surgery; renal failure treated by transplant;

Treatment of erectile

dysfunction

[F8(2) Any patient.]

[F9Treatment of a condition, other than erectile dysfunction, in respect of which the drug ordered is considered an appropriate treatment]
Oseltamivir (Tamiflu)
(1)

A patient who is aged 1 year or over and who is at clinical risk or a patient who is pregnant or aged 65 years or over, or who is aged under 65 years and is at risk of developing medical complications from influenza where—

(a)

F10...

(b)

the patient has an influenza-like illness; and

(c)

the patient can start therapy within 48 hours of the onset of symptoms.

(2)

Any patient suffering from influenza during an outbreak of pandemic influenza (influenza caused by a new virus subtype that has an increased and sustained transmission during a global outbreak of influenza), where the drug is ordered under arrangements for the distribution of the drug free of charge which are approved by the Department or are part the Regional Board’s antivirals distribution service.

Treatment of influenza
(3)

A patient who is aged 1 year or over and who is at clinical risk or a patient who is pregnant or aged 65 years or over, where—

(a)

F10...

(b)

the patient has been exposed to an influenza-like illness through being in close contact with someone with whom he lives who is or has been suffering from an influenza-like illness;

(c)

the patient is not effectively protected by vaccination against influenza because —

(i)

he has not been vaccinated because vaccination is contraindicated;

(ii)

he has not been vaccinated since the previous influenza season;

(iii)

he has been vaccinated but it has yet to take effect; or

(iv)

he has been vaccinated but the vaccine is not well matched to the strain of influenza circulating in the locality in which the patient resides or is or has been present;

(d)

the patient lives in a residential care establishment and another resident or member of staff of the establishment has an influenza-like illness; and

(e)

the patient can start prophylaxis within 48 hours of exposure to an influenza-like illness.

(4)

Any patient at risk from influenza during an outbreak of pandemic influenza (influenza caused by a new virus subtype that has an increased and sustained transmission during a global outbreak of influenza), where the drug is ordered under arrangements for the distribution of the drug free of charge which are approved by the Department or are part the Regional Board’s antivirals distribution service.

Prophylaxis of influenza
Zanamivir (Relenza)
(1)

A patient who is aged 5 years or over and who is at clinical risk or a patient who is pregnant or aged 65 years or over, or who is aged under 65 years and is at risk of developing medical complications from influenza where—

(a)

F10...

(b)

the patient has an influenza-like illness; and

(c)

in the case of a patient—

(i)

who has attained the age of 5 years but not the age of 13 years, that patient can start therapy within 36 hours of the onset of symptoms; and

(ii)

who is aged 13 years or over, that patient can start therapy within 48 hours of the onset of symptoms.

Treatment of influenza
(2)

Any patient at risk of or suffering from influenza during an outbreak of pandemic influenza (influenza caused by a new virus subtype that has an increased and sustained transmission during a global outbreak of influenza), where the drug is ordered under arrangements for the distribution of the drug free of charge which are approved by the Department or are part the Regional Board’s antivirals distribution service.

Prophylaxis or treatment of influenza.

Textual Amendments

F6Words in Sch. 2 substituted (31.12.2020) by S.I. 2019/784, reg. 19(2)(a) (as substituted by The Reciprocal and Cross-Border Healthcare (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1348), regs. 1, 17)

F7Words in Sch. 2 substituted (31.12.2020) by S.I. 2019/784, reg. 19(2)(b) (as substituted by The Reciprocal and Cross-Border Healthcare (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1348), regs. 1, 17)

Explanatory Note

(This note is not part of the Regulations.)

These Regulations make provision as to the drugs, medicines or other substance that may be ordered for patients in the provision of medical services under a general medical services contract within the meaning of Article 57 of the Health and Personal Social Services (Northern Ireland) Order 1972.

Regulation 2 and Schedule 1 list the drugs, medicines and other substances that may not be ordered under such a contract

Regulation 3 and Schedule 2 specify the drugs, medicinces and other substances that may be ordered under such a contract only in certain circumstances and sets out those circumstances.

(1)

S.I. 1999/283 (N.I. 1), see Article 3(6)

(2)

S.I. 1972/1265 (N.I. 14); Article 57D was inserted by Article 4 of S.I. 2004/311 (N.I. 2)