WHO Drug Information Vol. 20, No. 1, 2006 - World Health ...

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WHO Drug Information Vol 20, No. 1, 2006Biological MedicinesSupply of life-saving antisera:a growing need for concernAntisera represent the only therapy for thetreatment of envenomation and are essential, incombination with vaccination, for post-exposurerabies treatment. Antisera are produced by thefractionation of plasma obtained from horsesimmunized against the infectious agent or itstoxin. No alternative specific therapeutic treatmentis available to treat these diseases. Now, productionof effective equine-derived antisera indeveloped countries is being halted beforeaffected countries have developed the capacity tomanufacture enough quality products themselves.As a result, the world is now at imminent risk oflacking effective treatment for rabies and envenomationdue to snake or scorpion bites.Rabies is the tenth most common cause of deathdue to infections in humans. Although onehundred percent fatal, it is none the less apreventable disease if post-exposure treatmentwith antisera is readily available. An estimated 3to 4 million people would need to receive equinerabies antisera each year after being exposed toanimals suspected of carrying rabies. Almost halfof those requiring the antisera and those dying ofrabies are children less than 15 years of age.More than 99% of all human deaths from rabiesoccur in Africa, Asia and South America. Six to 8million vials of equine rabies antisera is requiredto cover these needs.There are close to 5 million snake bites each yearin Africa, Asia, and South America; 50 to 75%necessitating treatment by equine antivenoms toavoid deaths, amputation, or severe neurologicaldisorders. Unfortunately, equine antivenoms arelargely unavailable. Over 2.5 millions vials ofantivenoms would be needed to treat envenomationworldwide. Deaths or disability resulting fromthese accidents and diseases could be avoided ifa sufficient supply of antisera of controlled andassessed quality could be ensured, the logisticsof distribution improved, and education on clinicaluse provided.The shortage of antisera has become a verycritical health issue at global level. Most manufacturersin the developed world have abandonedproduction due to reduced clinical needs inindustrialized countries. Most remaining producersare located in developing countries, where theapplication of quality and safety standards needsto be improved. The decreasing number ofproducers and the fragility of the productionsystems in developing countries dramaticallyjeopardize the availability of antisera in Asia,Africa, the Middle East, and South America.In October 2005, the WHO Expert Committee forBiological Standardization (ECBS) recognized theextent of the problem and endorsed, as a priority,the role that WHO must play in supporting andstrengthening world capacity to ensure long-termand sufficient supply of safe antisera. TheInteragency Pharmaceutical Coordination Group,meeting in November 2005, also endorsed WHOaction.Prequalification of antiseraWHO is proposing to strengthen existing localproduction of antisera by building the technicalcapacity and expertise of regulatory authoritiesand also to develop a prequalification system forthese products that will ensure quality andfacilitate the procurement of antisera productsthrough procurement schemes. The WHO projectwould inherently facilitate transfer of technologiesto developing countries. WHO proposes to takethe following action to guarantee the productioncapacity of antisera and improve the supply ofsafe products:• Define a global standard for the production,quality control, and regulation of equine-derivedantisera to be used as a guidance by localregulatory authorities and manufacturers.• Conduct educational workshops at regional levelto help in the implementation of quality andsafety requirements for antisera productionfollowing the principles of good manufacturingpractices (GMP).5
Biological MedicinesWHO Drug Information Vol 20, No. 1, 2006• Train regulators, pharmaceutical inspectors andlocal manufacturers on the critical parameters ofthe production of antisera and GMP implementation.• Facilitate transfer of technology to developingcountries.• In the framework of the WHO prequalificationproject, initiate prequalification of antiseraproducers.References1. Burnouf, Th., Griffiths, E., Padilla, A. et al. Assessmentof the viral safety of antivenoms fractionated fromequine plasma. Biologicals, 32: 115–128 (2004).2. Theakston, R.D., Warrell, D.A,, Griffiths, E. Report ofWHO workshop on the standardization and control ofantivenoms. Toxicon, 41(5): 541–557 (2003).3. European Medicines Agency. Note for Guidance onProduction and Quality Control of AnimalImmunoglobulins and Immunosera for Human Use.EMEA (2002).4. Chippaux, J. P. Snake-bites: appraisal of the globalsituation. WHO Bulletin, 76(5): 515–524 (1998).5. World Health Organization. http://www.who.int/biologicalsLatest developments inbiological standardizationWHO’s biological standardization programmeprovides, promotes and implements global normsand standards for biological medicines, andstrives to provide the most relevant products forthe improvement of global health.The WHO Expert Committee on BiologicalStandardization (ECBS) was set up to develop,establish and promote technical standards toassure the quality, safety and efficacy of vaccines,biological therapeutics, blood products andselected in vitro diagnostic devices (IVDs). This isone of the longest standing WHO Committeesand has been operating since 1947. Among itsactivities, the WHO biological reference preparationsare important tools that allow the comparabilityof data worldwide in diverse fields of medicalpractice.The latest meeting of the ECBS was convened inGeneva from 24 to 28 October 2005. Expertswere invited from Belgium, Brazil, France,Germany, Japan, Russian Federation, UnitedKingdom, and United States of America. Otherparticipants and observers represented theCouncil of Europe, European Department for theQuality of Medicines, France; European PharmacopoeiaCommission, France; DevelopingCountry Vaccine Manufacturer’s Network, SerumInstitute of India; European Diagnostic ManufacturersAssociation, Germany; Eye Bank Associationof America, USA; International Association ofBiologicals, Switzerland; International Federationof Clinical Chemistry and Laboratory Medicine,Canada; International Federation of PharmaceuticalManufacturers Associations, Switzerland;GlaxoSmithKline Biologicals, Belgium; InternationalSociety of Blood Transfusion/EuropeanPlasma Fractionation Association, Netherlands;International Society on Thrombosis and Haemostasis,United Kingdom; Plasma ProteinTherapeutics Association, Belgium; and theUnited States Pharmacopeia.Current issues of regulatory concernThe means for preventing and controlling mostchronic diseases are well established, and includebiotechnological interventions. The number ofapproved innovative biotherapeutic products isexpected to increase substantially over thecoming years (e.g. some 500 monoclonal antibody-basedproducts are currently in the pipelinein the European Union and USA alone). Inaddition, the imminent patent expiration of manybiotechnology products will result in a substantialincrease in “follow-on” or “biosimiliar” productsWHO is receiving requests from countries foradvice on appropriate regulatory oversight forbiological therapeutics, since the potential forsuccess of therapeutic biological products used intreatment of a wide variety of chronic diseases isbeing tempered by concerns over quality, safetyand availability of such products. Inappropriateassay methods or poor potency determinationscan lead to life or death clinical problems; andadverse drug reactions — for example, unwantedantibody development in some individuals —could occur with a variety of products. Increasedrisks of infections have been seen with blockersof tumour necrosis factor α and the potential forsubstandard and counterfeit biotech productsrepresents an important matter of concern.The Committee proposed that WHO shouldorganize a meeting of interested parties to reviewthese issues in depth and help WHO developconsensus on the global needs, priorities andpotential role for global standardization in the area6
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