I1SCHEDULE 2DRUGS F7OR MEDICINES TO BE ORDERED ONLY IN CERTAIN CIRCUMSTANCES

Regulation 3

Annotations:
Commencement Information
I1

Sch. 2 in force at 1.4.2004, see reg. 1(1)

Amendments (Textual)

Column 1

Column 2

Column 3

Drugs

Patient

Condition

Clobazam

Any patient

Treatment of epilepsy

Cyanocobalamin Tablets

A patient who is a vegan or who has a proven vitamin B12 deficiency of dietary origin

Treatment or prevention of vitamin B12 deficiency

Locabiotal Aerosol

Any patient

Treatment of infections and inflammation of the oropharynx

Niferex Elixir 30ml Paediatric Dropper Bottle

Infants born prematurely

Prophylaxis and treatment of iron deficiency

Nizoral Cream

Any patient

Treatment of seborrhoeic dermatitis and pityriasis versicolor

F1Oseltamivir (Tamiflu)

F41

A patient F19... 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 for influenza, where—

a

the Welsh Ministers have notified general medical practitioners that the influenza virus is circulating in the community;

b

the patient has an influenza-like illness; and

c

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

2

A patient F19... 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 for influenza, where—

a

it has been determined in accordance with a community based virological surveillance scheme that influenza A or influenza B is circulating in the locality in which the patient resides or is present or was present at the time that the virus was circulating;

b

the patient has an influenza-like illness; and

c

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

3

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 Welsh Minsters.

Treatment of influenza

4

A patient F19... who is at clinical risk or a patient who is pregnant or aged 65 years or over, where—

a

the Welsh Ministers have notified general medical practitioners that the influenza virus is circulating in the community;

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.

5

A patient F19... who is at clinical risk or a patient who is pregnant or aged 65 years or over, where—

a

it has been determined in accordance with a community based virological surveillance scheme that influenza A or influenza B is circulating in the locality in which the patient resides or is present or was present at the time that the virus was circulating;

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.

6

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 Welsh Ministers.

Prophylaxis of infinfluenza

The following drugs for the treatment of erectile dysfunction—

Alprostadil F8...

F18Avanafil

F17... F9...

F17... F10...

Sildenafil F11...

Tadalafil F12...

F17... F10...

Vardenafil F13...

F141

The following patients with erectile dysfunction—

a

a man with erectile dysfunction who on 14th September 1998 was receiving a course of treatment under the Act, the National Health Service (Scotland) Act 19783 or the Health and Personal Social Services (Northern Ireland) Order 19724 for this condition with any of the following drugs—

  • Alprostadil (Caverject), (MUSE), (Viridal)

  • Apomorphine Hydrochloride (Uprima)

  • Moxisylyte Hydrochloride Assembly (Erecnos)

  • Sildenafil (Viagra)

  • Tadalafil (Cialis)

  • Thymoxamine Hydrochloride (Erecnos); or

F22b

a 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 as part of the health service for the condition mentioned in paragraph (ii) of this sub-paragraph with any of the drugs listed in sub-paragraph (a), or

F23c

a 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 as part of the health service 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

F5g

a man who has been diagnosed as suffering severe distress resulting from erectile dysfunction where the assessment has been made by a specialist service or GP under arrangements made with a Local Health Board to provide such assessmentsF15;

Treatment of erectile dysfunction

2

Any patient

F16Treatment of a condition other than erectile dysfunction, in respect of which the drug ordered is in receipt of a UK or EU marketing authorisation for the treatment of that condition

F1Zanamivir (Relenza)

F61

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

the Welsh Ministers have notified general medical practitioners that the influenza virus is circulating in the community;

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;

ii

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

2

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

it has been determined in accordance with a community based virological surveillance scheme that influenza A or influenza B is circulating in the locality in which the patient resides or was present at the time that the virus was circulating;

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;

ii

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

Treatment of influenza

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 Welsh Ministers.

Prophylaxis or treatment of influenza

In this Schedule—

  • F20...

  • F21“at-risk” means in relation to a patient, a patient who—

    1. a

      has chronic respiratory disease (including asthma and chronic obstructive pulmonary disease);

    2. b

      has significant cardiovascular disease, excluding a patient who has hypertension only;

    3. c

      has chronic renal disease;

    4. d

      is immunocompromised;

    5. e

      has diabetes mellitus;

    6. f

      has chronic liver disease; or

    7. g

      has chronic neurological disease;

  • F20...

  • EEA Agreement” means the Agreement on the European Economic Area signed at Oporto on 2nd May 19926 as adjusted by the Protocol signed at Brussels on 17th March 19937 and as amended so far as is relevant to these Regulations, by Decision of the EEA Joint Committee No 7/94 of 21st March 19948;

  • EEA State” means a State which is a contracting party to the EEA Agreement or Switzerland.

  • F3“Pandemic influenza” means influenza caused by a new virus subtype that has an increased and sustained transmission during a global outbreak of influenza;

  • F2“patient” has the same meaning as in the National Health Services (General Medical Services Contracts) (Wales) Regulations 2004;

  • F2“residential care establishment” means a place where persons reside on a long-term basis in order to receive continuing care.