Written Answers. - Vaccination Programme.

Denis Naughten

Question:

360 Mr. Naughten asked the Minister for Health and Children if, further to Parliamentary Questions Nos. 219, 220 and 221 of 6 March 2001, he will state the number of out-of-date vaccines administered in each health board area; the batch numbers involved in each board area; the measures which have been taken to date by each board to trace the persons administered with this out-of-date vaccine; and if he will make a statement on the matter. [7795/01]

Denis Naughten

Question:

362 Mr. Naughten asked the Minister for Health and Children the actions which he has taken to date to assess the prevalence of the administration of out-of-date vaccines under all the immunisation programmes supported by his Department; the conclusions drawn from such an investigation; and if he will make a statement on the matter. [7797/01]

Denis Naughten

Question:

363 Mr. Naughten asked the Minister for Health and Children the measures which he is implementing to ensure that out-of-date vaccines are not administered under departmental vaccination programmes; and if he will make a statement on the matter. [7798/01]

Denis Naughten

Question:

364 Mr. Naughten asked the Minister for Health and Children if, further to Parliamentary Questions Nos. 219, 220 and 221 of 6 March 2001, he will state the number of instances where, during health board investigations, it was not possible to trace the administration of out-of-date vaccine due to incomplete vaccination records; the health boards involved; and if he will make a statement on the matter. [7799/01]

Denis Naughten

Question:

365 Mr. Naughten asked the Minister for Health and Children the number of instances where health boards were unable to trace the administration of out-of-date vaccine due to incomplete vaccination records during the investigations to trace the Medeva polio vaccine; the health boards involved; and if he will make a statement on the matter. [7800/01]

Denis Naughten

Question:

366 Mr. Naughten asked the Minister for Health and Children if, further to Parliamentary Questions Nos. 219, 220 and 221 of 6 March 2001, he will state the number of vaccine doses which were administered after their expiry date; when he expects to receive final responses from all the health boards whose replies are outstanding; and if he will make a statement on the matter. [7801/01]

John Bruton

Question:

368 Mr. J. Bruton asked the Minister for Health and Children the number of instances where, during health board inquiries, it was unable to trace the administration of out-of-date vaccine due to incomplete vaccination records during the investigations by the Department to trace the Medeva polio vaccine; the health boards involved; and if he will make a statement on the matter. [7925/01]

Denis Naughten

Question:

383 Mr. Naughten asked the Minister for Health and Children the discussions which have taken place with the Irish Medicines Board regarding the labelling of vaccines following the discovery of the administration of out-of-date vaccine; if the manufacturers recommended expiry date refers to the start of the month or the end of the month; and if he will make a statement on the matter. [8068/01]

Denis Naughten

Question:

384 Mr. Naughten asked the Minister for Health and Children if he has had investigations made into a claim that polio vaccine was distributed to general practitioners by health boards when it was out of date; if general practitioners were aware of the fact that the vaccine was out of date at the time of administration; the health boards which were involved; and if he will make a statement on the matter. [8069/01]

Denis Naughten

Question:

385 Mr. Naughten asked the Minister for Health and Children if his attention has been drawn to the fact that health boards distributed polio vaccine to general practitioners that was on, or close to, its expiry date; the health boards involved in this regard; if this practice still continues; and if he will make a statement on the matter. [8070/01]

I propose to take Questions Nos. 360, 362 to 366, inclusive, 368 and 383 to 385, inclusive, together.

Following my announcement in December, 2000 in relation to the recent issue involving Medeva oral polio vaccine used in Ireland which contained human serum albumin produced from a plasma pool, where one of the donors had recently been diagnosed as having the variant form of Creutzfeldt-Jakob disease (vCJD), health boards were requested to have immunisation records examined in order to establish the extent of usage of the vaccine batches concerned. In the course of this examination information came to light which suggests that vaccine from the batches concerned was administered after its expiry date.

I requested expert advice in relation to the safety and efficacy aspects of this issue from the Immunisation Advisory Committee of the Royal College of Physicians of Ireland. The committee has advised that the efficacy of the vaccine is reduced if it is administered more than one month after the expiry date and that the vaccination should therefore be repeated in such cases. My Department has written to the chief executive officers of the health boards advising them that parents of any children who received any dose of oral polio vaccine more than one month after its expiry date should be contacted and advised of the need to have the immunisation repeated. The health boards were asked to advise general practitioners and all other relevant health professionals of the situation.
The health boards were requested to conduct a detailed examination of records in order to establish the extent to which the administration of oral polio vaccine after its expiry date had occurred in the period from January 1998 to December 2000. The information to date, which is not yet complete, suggests that in excess of 11,000 doses were administered out of date and that, of this quantity, approximately 5,000 doses were administered more than one month after their expiry date. It should, however, be noted that in any one-year period, some 100,000 children receive approximately 200,000 doses of oral polio vaccine as part of the primary and booster childhood immunisation programmes.
In view of the level of administration of oral polio vaccine after its expiry date, my Department has requested that health boards establish if children were given out-of-date vaccine. All records from 8 December 1995 (the date of the changeover to the GP delivery system) should be examined and health boards have also been asked to satisfy themselves that all vaccines (primary and booster) administered before this date (by health boards and general practitioners) were administered prior to the expiry date of the product concerned.
Health boards have also been asked to take appropriate measures in respect of vaccines administered from this point forward to ensure the validation of all key information i.e. patient name, batch number and expiry date by cross reference to registration and supply databases.
In addition, health boards have been requested to ask their primary care units, where there is no confusion about out-of-date information on the packages, to examine how the administration of out-of-date vaccines occurred and the measures which should be put in place to prevent a recurrence. This matter has also been brought to the attention of the Irish College of General Practitioners, which have been asked to review the matter and to consider the development of protocols in respect of vaccine administration.
This incident highlighted a number of issues in relation to the management and delivery of vaccines and in particular vaccines under the childhood immunisation programme. In view of this, health boards have been asked to examine systems and procedures currently in place, identify shortcomings where these exist and put in place revised systems/procedures as a matter of urgency.
In addition, as a result of my concern about the issuing of vaccine after its expiry date, I have asked the chief executive officers of the health boards to establish a national immunisation steer ing committee, which is addressing a wide range of issues relating to the primary childhood immunisation programme. This will include consideration of the protocols for administration of vaccines, whether new mechanisms need to be developed to guard against possible use of vaccine which has passed its expiry date and to ensure that vaccines are administered in accordance with best practice.
The following table sets out the number of oral polio vaccine doses, based on the latest information obtained from the health boards, which were administered after the expiry date. This information is provisional and may be subject to revision as further information is provided.

No of doses (

No of doses (>one month after expiry date)

Total

Eastern Regional Health Authority

887

699

1,586

Midland Health Board

748

724

1,472

Mid-Western Health Board

991

773

1,764

North Eastern Health Board

101

52

153

North Western Health Board

342

205

547

South Eastern Health Board

1,294

610

1,904

Southern Health Board

1,679

1,762

3,441

Western Health Board

485

549

1,034

Totals

6,527

5,374

11,901

The health boards have confirmed that they have provided, or are in the process of providing, lists of children who received vaccine more than one month after its expiry date to general practitioners in their area. General practitioners have been asked to validate these lists against their own records and recall children as appropriate for revaccination.
Based on data held by health boards, they have indicated that there is no evidence to suggest that oral polio vaccine was distributed to GPs after its expiry date. However, due to the short shelf life of some vaccine, the product was, in some instances, delivered close to its expiry date.
The responses from the health boards on the number of instances where, during health board investigations, the boards were unable to trace the administration of out of date vaccine due to incomplete vaccination records require further clarification and the information will be furnished to the Deputy as soon as possible.
The following table indicates the Medeva/Evans and Smithkline Beecham batch numbers, which have been notified to date, that were administered after the expiry date.

Smithkline Beecham

Evans

Midland Health Board

S2442A1A

E7210/01C

S776A1

751124

S777A1A

751312

S779A1

751722

S780A1

751724

S781A1

752686

S782A1

E7210/01A

S783A1

E7211/01A

S783A1B

E7211/01B

S783A2

E7212/01A

S781A1A

E7212/02A

S125NS

E7212/02B

S125PG

E7212/02C

S125PK

E7213/01A

S125VB

E7213/02A

S125VD

E7213/02B

Smithkline Beecham

Evans

S125VP

E8214/01A

S125WR

E8214/01B

S125XC

E8215/01A

S125XR

E8215/01B

S125XS

E8217/01A

S126AS

E8217/02A

S2442A1

E8415/02A

North-Eastern Health Board

S777A1A

E7212/02B

S779A1

E7213/01A

S780A1

E7213/02B

S781A1

E8214/01A

S782A1

E8215/01A

S793A1

E8215/01B

North-Western Health Board

S125PG

751124

S125PK

E7212/01A

S125VB

E7212/02B

S125VD

E7213/01A

S125WR

E7213/02A

S125XS

E7213/02B

S776A1

E8214/01B

S779A1

E8215/01A

S779A1A

E8215/01B

S780A1

E8217/01A

S781A1

E8415/02A

S782A1

S783A1

South-Eastern Health Board

S125PG

751124

S125PK

751312

S125VB

751724

S125VD

E7212/01A

S125VP

E7212/02A

S125WR

E7212/02B

S125XC

E7212/02C

S125XS

E7213/01A

S776A1

E7213/01B

S779A1

E7213/02A

S780A1

E7213/02B

S781A1

E8214/01A

S782A1

E8214/01B

S783A1

E8215/01A

E8215/01B

E8217/01A

E8217/02A

E8415/02A

Smithkline Beecham

Evans

Southern Health Board

S125NS

751124

S125PG

751312

S125PK

751722

S125VB

751724

S125VD

752686

S125VP

E7210/01A

S125WR

E7210/01C

S125XC

E7211/01A

S125XR

E7211/01B

S125XS

E7212/01A

S126AS

E7212/02A

S2442A1

E7212/02B

S2442A1A

E7212/02C

S776A1

E7213/01A

S777A1A

E7213/02A

S779A1

E7213/02B

S780A1

E8214/01A

S781A1

E8214/01B

S781A1A

E8215/01A

S782A1

E8215/01B

S783A1

E8217/01A

S783A1B

E8217/02A

S783A2

E8415/02A

Western Health Board

E7213/02BE8214/01BE8214/01AE8215/01BE8215/01AE7213/01AE7213/02A

This information may be subject to revision as further records are examined. The other health boards were unable to provide the information requested in the time available. I will forward this information to the Deputy as soon as it is received.
The Department is involved in ongoing communication with the Irish Medicines Board regarding the labelling of vaccine-expiry-date issues. The Irish Medicines Board has indicated that it is investigating issues relating to expiry date practice and will report once these investigations have been completed. The board has also indicated that it intends to re-emphasise the responsibilities of authorisation holders, in their next newsletter and on their website, in relation to setting expiry dates. These requirements are already established in good manufacturing practice and other guidelines. The expiry date when expressed as a month-year is generally accepted to indicate that the product in question may be used until the last day of that month.
I am concerned that a significant amount of oral polio vaccine was issued after its expiry date during the period from January 1998 to December 2000. This only came to light as a result of my announcement in December 2000 relating to oral polio vaccine administered during this period which contained human serum albumin produced from a plasma pool where one of the donors had recently been diagnosed as having the variant form of Creutzfeldt-Jakob disease. The situation by which vaccines are administered after the expiry date is far from acceptable and that is why I, along with relevant agencies, have taken the range of measures necessary to ensure a comprehensive examination of the administration of the primary immunisation programme.