One-sixth of all re-is­sued ‘sleep dis­or­der’ jabs un­ac­counted for

Irish Independent - - News - Ralph Riegel

MORE than one-sixth of the re-is­sued stock­pile of a drug, now at the cen­tre of nar­colepsy or sleep dis­or­der fears, is ef­fec­tively un­ac­counted for.

The rev­e­la­tion came as it emerged an un­known num­ber of Irish chil­dren re­ceived a sec­ond dose of the Pan­dem­rix vac­cine in 2011 af­ter the Health Ser­vice Ex­ec­u­tive (HSE) ad­mit­ted it did not han­dle all sub­se­quent vac­cine stock dis­pos­als.

Pan­dem­rix was re-is­sued by the HSE to Irish GPs and clin­ics amid fears of a short­fall in the nor­mal win­ter flu vac­cine in early 2011.

How­ever, it was with­drawn just weeks later when stud­ies in Fin­land and Swe­den in­di­cated Pan­dem­rix could be linked to a surge in the num­ber of nar­colepsy or sleep dis­or­der cases be­ing re­ported.

Now, the Irish Independent has learned that the HSE did not han­dle all vac­cine dis­pos­als in 2011.

While two-thirds of Ire­land’s GPs and clin­ics ac­cepted at least one box of Pan­dem­rix doses in 2011, the HSE only re­ceived re­turned vac­cine stocks from half of those prac­tices from March 28, 2011, when the vac­cine was re­called.

Im­pos­si­ble

The re­main­der, slightly less than half the na­tional dis­tri­bu­tion stock, was dis­posed of by GPs and clin­ics them­selves through al­ter­na­tive meth­ods to the HSE drug re­turn scheme.

That makes it dif­fi­cult, if not im­pos­si­ble, for the HSE to dis­cover pre­cisely how many chil­dren may have re­ceived doses.

Sligo TD and nar­colepsy cam­paigner Marc MacSharry said the is­sue raised ob­vi­ous con­cerns.

“Most wor­ry­ingly, when the HSE did re­call the Pan­dem­rix vac­cines pro­vided to GPs and clin­ics na­tion­wide for use as a sub­sti­tute for the or­di­nary flu vac­cine, just less than 50pc were ever re­turned.

“Some wor­ry­ing ques­tions arise: were they used on pa­tients? Were they dis­posed of ?

“And in any event, how many were ad­min­is­tered to pa­tients? To whom? Have they been told?

“And how many are suf­fer­ing the symp­toms of nar­colepsy fol­low­ing this?”

The Fianna Fáil TD said it was clear there was a re­spon­si­bil­ity to in­form any­one who may in­ad­ver­tently have re­ceived Pan­dem­rix in 2011.

Sound, the group cam­paign­ing on be­half of nar­colepsy suf­fer­ers, ex­pressed alarm at the rev­e­la­tion.

“Po­ten­tially more than one­sixth of the vac­cines is­sued to GPs is un­ac­counted for – so where are they?” asked Sound co-founder Tom Matthews.

The HSE in­sisted it was “likely that very few doc­tors pre­scribed Pan­dem­rix” dur­ing the three month re-is­sue pe­riod in 2011.

How­ever, the Irish In­de­pend- ent re­vealed that at least one fam­ily had a mother and two chil­dren treated with Pan­dem­rix in 2011.

The chil­dren got a sec­ond dose hav­ing al­ready been treated in 2009 with the vac­cine at the height of the swine flu fears.

The fam­ily only dis­cov­ered the Pan­dem­rix dou­ble dose when they de­manded their vac­ci­na­tion records af­ter one child de­vel­oped chronic nar­colepsy.

Pan­dem­rix was ini­tially used from au­tumn 2009 to March 2010 but was then with­drawn and placed into stor­age.

The Gov­ern­ment, as de­manded by the vac­cine man­u­fac­turer Glax­oSmithK­line (GSK), granted the firm a full in­dem­nity in 2009 to fast-track the drug.

Stock­piles of the Ger­man-made vac­cine were then re-is­sued in Jan­uary 2011 when fears mounted that GPs and clin­ics could run short of the nor­mal win­ter flu vac­cine.

The Gov­ern­ment had orig­i­nally sourced a to­tal of eight mil­lion doses of Pan­dem­rix at a re­ported cost of €80m.

“In early Jan­uary 2011, there were in­creas­ing lev­els of in­fluenza ill­ness with a con­sid­er­able de­mand for sea­sonal flu vac­cine and a re­sult­ing pres­sure on ex­ist­ing vac­cine sup­ply,” a HSE spokesper­son ex­plained.

“The HSE had a lim­ited sup­ply of sea­sonal flu vac­cine with more ex­pected within the fol­low­ing two weeks.

“In order to en­sure that all GPs had suf­fi­cient vac­cine sup­plies, the HSE Na­tional Cold Chain Ser­vice of­fered all GP prac­tices one box of 50 vials of Pan­dem­rix vac­cine (equiv­a­lent to 500 doses but likely to be much less as the vac­cine came in multi-dose vials and once a vial was opened it had to be dis­carded af­ter 24 hours).”

Across Ire­land, two-thirds of GPs and clin­ics ac­cepted sup­plies.

“(But) the de­liv­ery of sea­sonal flu vac­cine ar­rived sooner than ex­pected and this was dis­trib­uted to all who re­quired it,” the HSE of­fi­cial ex­plained.

“As we were not in­formed of any site that ran out of sea­sonal flu vac­cine, it is likely that very few doc­tors pre­scribed Pan­dem­rix.”

How­ever, all vac­cine stocks were not re­turned to the HSE.

“GP prac­tices were asked to re­turn any un­used Pan­dem­rix and over half of the prac­tices re­turned stock.

“GPs are not obliged to use the vac­cine re­turns ser­vice and may dis­pose of un­wanted vac­cines through other waste dis­posal ser­vices.”

Photo: Leon Far­rell/Pho­to­call Ire­land.

A United Drug worker with a de­liv­ery of swine flu vac­cine in Oc­to­ber 2009.

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