Statutory Instruments

2004 No. 3215

NATIONAL HEALTH SERVICE, ENGLAND

The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2004

Made

7th December 2004

Laid before Parliament

13th December 2004

Coming into force

3rd January 2005

The Secretary of State for Health in exercise of the powers conferred upon him by sections 28U and 126(4) of the National Health Service Act 1977(1) and of all other powers enabling him in that behalf, hereby makes the following Regulations:—

Citation, commencement, interpretation and application

1.—(1) These Regulations may be cited as the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2004 and shall come into force on 3rd January 2005.

(2) These Regulations apply to England only.

(3) In these Regulations, “the Prescription of Drugs etc. Regulations” means the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004(2).

Amendment of Schedule 2 to the Prescription of Drugs etc. Regulations

2. In Schedule 2 to the Prescription of Drugs etc. Regulations (drugs, medicines and other substances that may be ordered only in certain circumstances)—

(a)In the appropriate alphabetical place in the table having regard to the name of the drug, insert respectively in columns 1, 2 and 3—

“Oseltamivir (Tamiflu)

(1) At-risk adult and child patients 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.

Treatment of influenza

(2) At-risk patients aged 13 years and older 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;

(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.

Prophylaxis of influenza”; and

“Zanamivir (Relenza)

At-risk adult patients 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.

Treatment of influenza”.

(d)After the words “in this Schedule—” insert in the appropriate alphabetical place—

““ at-risk” means an adult or child patient or a patient over the age of 13 who—

(a)

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

(b)

has significant cardiovascular disease, excluding an adult or child patient who has hypertension only;

(c)

has chronic renal disease;

(d)

are immunocompromised;

(e)

has diabetes mellitus; or

(f)

is aged 65 years or over;”;

““child” means any person under the age of 16;”;

““patient” has the same meaning as in the National Health Services (General Medical Services Contracts) Regulations 2004(3);”; and

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

Signed by authority of the Secretary of State for Health

Warner

Parliamentary Under Secretary of State,

Department of Health

7th December 2004

Explanatory Note

(This note is not part of the Regulations)

These Regulations amend the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004 (“the Prescription of Drugs etc. Regulations”).

Schedule 2 to the Prescription of Drugs etc. Regulations lists drugs, medicines and other substances which may be ordered only in certain circumstances under a general medical services contract within the meaning of section 28Q of the National Health Service Act 1977(4). These Regulations add Oseltamivir (Tamiflu) and Zanamivir (Relenza) to that list, and set out the circumstances in which they may be ordered.

(1)

1977 c. 49; section 28U was inserted by section 175(1) of the Health and Social Care (Community Health and Standards) Act 2003 (c. 43).

(2)

S.I. 2004/629.

(3)

S.I. 2004/291.

(4)

Section 28Q was inserted into the Act by section 175(1) of the Health and Social Care (Community Health and Standards) Act 2003 (c. 43).