WHO Drug Information Vol. 24, No. 4, 2010

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WHO Prequalification ProgrammesWHO Drug Information Vol. 24, No. 4, 2010It is expected that the time taken to reachprequalification will be made shorter forFPPs that are manufactured using WHOprequalifiedAPIs, than for FPPs that aremanufactured using APIs that have notpreviously been evaluated by WHO PQP.An APIMF that has already been acceptedby WHO in relation to the prequalificationof an FPP may be includedin the WHO List of Prequalified APIswithout reassessment or re-inspection.This is contingent upon the APIMFmeeting certain administrative criteria andthe relevant manufacturing site havingpassed inspection by WHO or a stringentregulatory authority.Selection of APIs for inclusion in the firstInvitation was based on APIs for whichAPIMFs have already been submitted inconnection with evaluation of an FPP.PQP anticipates that future Invitations willbe expanded to incorporate additionalAPIs. New Invitations will be posted onthe PQP web site and manufacturers aretherefore encouraged to regularly accesshttp://www.who.int/prequal.New on-line database forWHO prequalified vaccinesA new database for vaccines prequalifiedby WHO by type of vaccine, manufacturerand country of manufacture is nowavailable on WHO’s web site (1). This willenable immunization programme managers,procurement agencies, regulatoryauthorities, and other partners to consultsummary pages for each prequalifiedvaccine and seek information such asdate of prequalification, vaccine presentation,route of administration, shelf life,packaging, and cold chain requirements.The ultimate goal of WHO’s prequalificationprogramme for vaccines is to ensurethat all countries have access to vaccinesthat meet international standards ofquality, safety and efficacy and areappropriate for the target population. Therigourous prequalification process includes• review of comprehensive documentationon production methods, vaccine composition,quality control and clincial experience;• independent testing for consistency byWHO-accredited laboratories; and• site audits of the manufacturer to ensurethat vaccine and production methodsconform to international standards.Complaints about vaccine quality andreports of adverse events followingimmunization are investigated by WHO.Furthermore, United Nations procurementagencies only purchase vaccines thathave been prequalified by WHO.The system is widely credited with contributingto the growing number andproportion of quality vaccines beingsupplied by companies in developingcountries, such as Brazil, Cuba, India,Indonesia and Senegal.The prequalification pages on WHO’sweb site contain sections on overallgoals, principles, process and prioritysettingfor WHO vaccine prequalification,together with guidance documents forvaccine manufacturers.References1. Database on prequalified vaccines at http://www.who.int/immunization_standards/vaccine_quality/PQ_vaccine_list_en/en/index.html2. Further information on the WHO Prequalificationof Vaccines Programme at http://www.who.int/immunization_standards/vaccine_quality/vq_index/en/index.html298
WHO Drug Information Vol. 24, No. 4, 2010Safety and Efficacy IssuesH1N1 influenza vaccine:narcolepsyEuropean Union — The EuropeanMedicines Agency’s (EMA) Committee forMedicinal Products for Human Use(CHMP) has reviewed all available dataon the suspected link between narcolepsyand Pandemrix® an H1N1 influenzavaccine. The Committee concluded thatthe available evidence was insufficient todetermine whether there is any linkbetween Pandemrix® and reports ofnarcolepsy, and that further studies werenecessary to fully understand this issue.The Committee agreed that at present thebenefit-risk balance for Pandemrix®continues to be positive and that whilethe review is still ongoing there was noneed for Europe-wide restrictions on use.Narcolepsy is a rare sleep disorder thatcauses a person to fall asleep suddenlyand unexpectedly. Its precise cause isunknown, but it is generally considered tobe triggered by a combination of geneticand environmental factors.As per 17 September 2010, there were81 reports from healthcare professionalssuggestive of narcolepsy, all collectedthrough spontaneous reporting systems.Of these, 34 reports come from Sweden,30 from Finland, 10 from France, six fromNorway and one from Portugal. In addition,there are a further 13 consumerreports from Sweden and two fromNorway. The age range of patients isbetween four and 52 years.Reference: EMA Press Release, EMA/CHMP/588294/2010, 23 September 2010 at http://www.ema. europa.euStatins: interstitial lungdiseaseCanada — Interstitial lung disease (ILD)is a heterogeneous group of disordersthat can be acute or chronic and maylead to pulmonary fibrosis and pulmonaryinsufficiency (1, 2). Signs and symptomsinclude difficulty breathing, nonproductivecough and diffuse crackles heard onauscultation. ILD has been reported inassociation with several drugs, such asamiodarone, azathioprine, carbamazepine,cyclophosphamide, methotrexateand nitrofurantoin (1, 2).During the past 15 years, 29 cases of ILDsuspected of being associated with HMG-CoA reductase inhibitors (statins) havebeen published (3–14). Of these, 16describe a positive dechallenge with orwithout immunosuppressive treatment(3,4, 6, 8–11,14 ) and three cases describeda positive rechallenge (4, 9). Insome of these reports, ILD was part ofsystemic clinical features consistent withpotential drug-induced diseases such aslupus (7), polymyositis (4, 12), dermatomyositis(5) and Churg-Strauss syndrome(14).A systematic review of the suspectedassociation between ILD and statins hasrecently been published (15). Althoughthe mechanism of potential statin-inducedILD is unknown, some authors suggestedit could be mediated by the inhibition ofphospholipases; an effect of the statinson mitochondrial metabolism; or immunemediated (15).As of 31 March 2010, Health Canadareceived 8 adverse reaction reports ofILD, or pathologies associated with ILD,299
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WHO Drug Information Vol. 24, No. 4, 2010

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