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WHO Drug Information Vol WHO Drug Information Vol. 27, No. 1, 2013 WHO Drug Information Contents Access to Blood Products Combined contraceptives: venous Access to safe and effective blood and arterial thromboembolism 19 products in low and middle income Fibrin sealant spray: gas embolism 19 countries 3 Corticosteroids: musculoskeletal adverse events 20 Current Topics Mechanism to combat substandard/ Regulatory Action and News spurious/falsely-labelled/falsified/ Herbal medicines: strengthening counterfeit medical products 6 assessment methodology and Speeding up access to quality improved communication 22 medicines in Africa 6 Advanced therapies: incentives and PQM technical support for strengthened interaction 22 prequalification of medicines 8 Methodologies in pharmacovigilance International Generic Drug Regulator’s and pharmacoepidemiology 23 Pilot Project 9 Nicotinic acid/laropiprant: suspension recommended 23 Safety and Efficacy Issues Bevacizumab approved for meta- Tolvaptan: risk of liver injury 10 static colorectal cancer 24 Roflumilast: risk of suicidal behaviour 10 Mercury free healthcare 24 Sodium picosulfate/magnesium Ocriplasmin: approved for vitreo- citrate: convulsions 11 macular traction 25 Risperidone and rhabdomyolysis 12 India: clinical trial conditions Docetaxel: serious respiratory- amended 25 related adverse reactions 13 eSubmission Gateway release II Zolpidem: impaired activity 14 and eSubmission web client 26 Combination treatment with telaprevir, Deferasirox approved for nontrans- peginterferon alfa and ribavirin: fusion-dependent thalassaemia 26 serious skin reactions 14 Pomalidomide approved for Dabigatran etexilate mesylate: not advanced multiple myeloma 27 for patients with mechanical Nalmefene approved for reduction prosthetic heart valves 15 of alcohol consumption 27 Sodium oxybate with alcohol or Mipomersen sodium and lomitapide drugs: respiratory depression 15 approved for inherited cholesterol Statins: risk of increased blood disorder 27 sugar levels and diabetes 15 Memantine: Imatinib mesilate: Immunomodulatory medicines: marketing authorization application progressive multifocal leuko- withdrawal 28 encephalopathy 16 Imatinib mesilate: marketing Thyroxine and fractures 17 authorizaation application Oral bowel cleansing products: withdrawal 29 serious electrolyte disturbances 18 ... (continued) 1 WHO Drug Information Vol. 27, No. 1, 2013 Contents (continued) Recent Publications, Information International course on dengue 33 and Events Paediatric ACTs for the treatment of WHO/WIPO/WTO: health innovation uncomplicated malaria 33 and access to medicines 29 EPN study: availability and pricing of Consultation Document children’s medicines in Ghana 30 The International Pharmacopoeia IOM report on substandard and 4. Reference Substances and falsified medicines 30 Reference Spectra 35 HIFA: Information for healthcare providers 31 International Nonproprietary New pregnancy registry protocol 32 Names Malaria: rapid diagnostic testing 33 Recommended List No. 69 41 WHO Drug Information Digital library e-mail table of contents subscriptions available at: http://www.who.int/druginformation 2 WHO Drug Information Vol. 27, No. 1, 2013 Access to Blood Products Access to safe and effective not suitable for further manufacture. blood products in low and Generally accepted international standards require, among other things, middle income countries appropriate freezing and cold storage Blood products include blood and blood conditions, traceability of donors, testing components produced as single-donor to lower the residual viral risk, regulatory products for direct transfusion, so-called controls, quality systems and adherence labile blood components (i.e., red blood to good manufacturing practices (GMP). cells, platelets and plasma), as well as Improvement in quality standards, know- numerous plasma-derived medicinal how and production processes in blood products (e.g., albumin, polyvalent and establishments should therefore directly specific immunoglobulins, and blood contribute to reducing the rate of trans- coagulation factors) that are prepared mission by transfusion of blood-borne in fractionation facilities from pools of infectious diseases. thousands of plasma units. Even while the need for plasma products grows, a substantial and increasing In high-income countries (HIC), each unit volume of recovered plasma in LMIC is of whole blood collected is separated into currently being wasted. This volume has several therapeutic blood components to been estimated — based on the global both deliver the most effective treatment approximations of whole blood donations (component therapy) and to make most and the volume of recovered plasma efficient use of a precious and limited currently used for direct transfusion or for human resource. The plasma component fractionation — to be close to 9.3 million can be used directly for transfusion, or litres each year. This volume corresponds sent for further manufacture into thera- to more than 40% of world supply of peutic plasma protein concentrates. recovered plasma. Access to safe and effective blood The volume of discarded plasma is products is a major challenge in low and expected to increase substantially as middle income countries (LMIC) where the volume of blood collected to meet local blood establishments may have projected LMIC needs for red cells (the very basic facilities and systems, where primary determinant of the number of quality and safety standards need to be whole blood collections) increases and established or strengthened, and where as blood component therapy becomes blood supplies may be insufficient to meet more widely applied. This has been the medical needs. experience supported by decades of clinical data from HIC. World Health Assembly resolution WHA63.12, in addressing the avail- The challenge now is to support LMIC ability, quality and safety of blood investment in improving the quality of products, points out that in many LMIC the blood they collect by improving the a large percentage of human plasma, knowledge base, infrastructure, produc- separated from whole blood is currently tion standards and regulatory oversight in discarded. This wastage occurs in large blood establishments and by emphasizing part because the separated plasma is the positive impact that such a move 3 Blood Products and Components WHO Drug Information Vol. 27, No. 1, 2013 will have on public health. The short- epidemiology and demographics of term investment in improving local markers of blood-borne infections. production standards in blood establish- ments of countries currently discarding Overall, it is imperative for governments large volumes of plasma is a means to in LMIC to address the large wastage of improve access to essential plasma- blood and plasma estimated to occur, derived medicinal products while at the and it is clearly in their interest to do so. same time improving the quality and The process, methods, and timelines safety of the other blood components, the for improving blood collection systems safety and health of the blood donor and will vary in different countries. The gaps the long-term benefits to the public health between HIC and LMIC are significant, of national and worldwide populations. but differ from region to region. Suitable regulatory oversight is often lacking, and To examine and analyze the available in its absence progress will be faltering data, the drivers of technology transfer and at risk. Sustainability of aid provided and local production in blood establish- to many countries, largely because of the ments, and the potential benefits and AIDS pandemic, will only occur with the risks that arise from such an initiative, exertion of national will and locally appro- WHO convened a stakeholders’ work- priate regulatory and legislative action. shop in Geneva on 14–15 June 2012. Participants included representatives Another initiative intended to improve from national regulatory authorities, the safety, availability, quality, and blood collection organizations, patient accessibility of blood products is the organizations, national blood proposal endorsed by the WHO Blood programmes, plasma fractionators, Regulators Network to add whole blood members of the WHO Blood Regulators and red blood cells to the WHO Model Network, nongovernmental organizations, List of Essential Medicines (EML). This public health and funding agencies. proposal was also endorsed by the 63rd WHO Expert Committee on Biological The report of these deliberations will be Standardization and the 15th Interna- published in April 2013 and posted at tional Conference of Drug Regulatory the web site address: http://www.who.int/ Authorities. Whole blood and red cells bloodproducts. The report examines the meet the generally accepted definition volume of plasma separated from whole of medicines; they are among the most blood that is currently wasted worldwide widely prescribed therapies (an estimated and identifies challenges and opportuni- 90 million units annually worldwide), and ties and the key steps needed to improve are credited with saving millions of lives the current situation. each year. The steps proposed should have multiple Blood is a national resource, derived from benefits, at the national, regional and voluntary public donations and processed global levels. They include strengthening into medicines to advance that same local production capacity in blood public’s health. Blood is a unique establishments in countries currently biological in that the “raw material” is discarding
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