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

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WHO Drug Information Vol 20, No. 1, 2006General InformationRevised WHO treatmentrecommendations for malariaGlobal malaria control is being threatened on anunprecedented scale by rapidly growing resistanceof Plasmodium falciparum to conventionalmonotherapies such as chloroquine, sulfadoxinepyrimethamine(SP) and amodiaquine. Multidrugresistantfalciparum malaria is widely prevalent inSouth-East Asia and South America and nowAfrica, the continent with highest burden ofmalaria, is also being seriously affected.In response to this situation, WHO recommendsthat treatment policies for falciparum malaria in allcountries experiencing resistance to monotherapiesshould be combination therapies,preferably those containing an artemisininderivative.The therapeutic options currently recommendedby WHO are:• artemether/lumefantrine• artesunate plus amodiaquine• artesunate plus sulfadoxine/pyrimethamine (inareas where SP efficacy remains high)• amodiaquine plus sulfadoxine/pyrimethamine, inareas where efficacy of both amodiaquine andsulfadoxine/pyrimethamine remains high (mainlylimited to West Africa).• artesunate plus mefloquine, an additionalrecommended combination treatment which isreserved for areas of low transmission.Expanding access to artemisinincombination therapyOver the last three years around 20 countries(seven in Africa) have updated their treatmentpolicies to include artemisinin combinationtherapy (ACT) as first or second-line treatment ofmalaria.The single non-artemisinin-based combinationtherapy (amodiaquine plus SP), listed aboveamong WHO recommended options is reservedfor countries which, for whatever reason, areunable to move into ACT. However, the limitationsof this option should be noted:• The number of countries where efficacy is highof both amodiaquine and SP is limited andmainly restricted to West Africa.• As both amodiaquine and SP are currently inwide usage as monotherapies it is unlikely thatthe adoption of this combination therapy willsignificantly delay the spread of resistance toeither drug. Therefore, the adoption of combinationtherapy with amodiaquine plus SP is likelyto be a short-term solution.• Even in areas where the efficacy of both amodiaquineand SP remain high, their combined usewill compromise the useful therapeutic life ofboth, and thus endanger their potential use aspartner drugs for artesunate in ACT.• There is currently no replacement for SP as adrug for Intermittent Preventive Treatment (IPT)in pregnancy. Rather than compromise itstherapeutic life by using it as a component of acombination therapy, SP should be reserved forIPT.• As the process of drug policy change andimplementation is resource and time intensive(experience shows it to take from one to threeyears), all efforts for improving access totreatment should be directed towards implementingthe most effective and durable treatmentpolicy.One of the principal reasons for countries wishingto adopt non artemisinin-based combinations istheir lower price. However, multiple financialmechanisms are now available in countries, andinternational support is being mobilized to helpcountries adopt ACT, and an increasing number ofcountries are now replacing ineffectivemonotherapies.To facilitate access to ACT, WHO will continue toinspect manufacturers of artemisinin derivativesas part of the WHO prequalification project,33
General InformationWHO Drug Information Vol 20, No. 1, 2006negotiate price agreements with manufacturers,engage in international procurement, and set upsystems of pharmacovigilance. A service formalaria medicines and supplies has been establishedby WHO and RBM partners to facilitateaccess to ACT within a larger facility for improvingaccess to medicines and supplies for HIV-AIDS,TB and Malaria.Consistent with WHO recommendations, malariaendemic countries which are experiencingresistance to currently used antimalarial drugmonotherapies (chloroquine, sulphadoxine/pyrimethamine or amodiaquine) should changetreatment policies to the highly effective artemisinin-basedcombination treatments (ACT).References1 World Health Organization. The Use of AntimalarialDrugs. Report of a WHO Informal Consultation. WHOunpublished report. WHO/CDS/RBM/2001.33.2 World Health Organization. Antimalarial Drug CombinationTherapy, Report of a WHO Technical Consultation.WHO unpublished report . WHO/CDS/RBM/2001.35.3. World Health Organization. New malaria treatmentguidelines issued by WHO. News Release, WHO/2, 19January 2006.Quality assurance: latest guidanceThe purpose of the WHO Expert Committee onSpecifications for Pharmaceutical Preparations isto provide guidance to WHO and Member Statesconcerning the quality of medicines. Within thisbroad mandate, it focuses on good manufacturingpractices and provides regulatory guidance textsfor interrelated activities on bioequivalence,prequalification, stability testing, fixed-dosecombinations, and counterfeit and substandardmedicines. Guidelines, specifications and internationalnomenclature developed under the aegis ofthis Expert Committee serve all Member States.During its most recent meeting in Geneva from24 to 28 October 2005, the Expert Committeemade recommendations in various specific workareas related to quality assurance. Quality controlissues discussed target essential medicines andthose used in the treatment of large populationsfor which no international quality requirementsmay be available. The following new standardsand guidelines were approved.1. ICRS, List of available International ChemicalReference Substances.2. Supplementary guidelines on GMP for heating,ventilation and air-conditioning systems.3. Good manufacturing practices: supplementaryguidelines on GMP for the manufacture ofherbal medicines.4. Good manufacturing practices: Validation.5. Good distribution practices (GDP) for pharmaceuticalproducts.6. Model Quality Assurance System for Assessmentof Procurement Agencies.7. Guidelines on registration requirements toestablish interchangeability of multisource(generic) pharmaceutical products.8. Proposal to waive in-vivo bioequivalencerequirements for the WHO model List ofEssential Medicines, immediate release, soliddosage forms.9. Guidelines for organizations performing in vivobioequivalence studies.10. International Pharmacopoeia monographs on:abacavir sulfate, efavirenz, lamivudine, stavudine,zidovudine, nelfinavir mesilate tablets,nelfinavir mesilate oral powder, and saquinavirmesilate capsulesfixed-dose antituberculosis medicines in theirfinished dosage forms: rifampicin tablets,rifampicin capsules, rifampicin + isoniazidtablets, rifampicin + isoniazid + pyrazinamide +ethambutol HCl tablets, isoniazid + ethambutolHCl tablets, and rifampicin + isoniazid +pyrazinamide tablets.In addition, the following revisions were adoped.• WHO Guidelines for stability testing of pharmaceuticalproducts containing well establisheddrug substances in conventional dosage formsAnnex 5, WHO Technical Report Series 863,1996, and Update, WHO Technical ReportSeries 908, 2003. http://www.who.int/medicines34
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