WHO Drug Information Vol
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WHO Drug Information Vol. 27, No. 2, 2013 WHO Drug Information Contents Quality and Safety of Medicines Levothyroxine: licence suspension 111 WHO project for the surveillance Strontium ranelate: restricted use 112 and monitoring of SSFFC medical Tetrazepam-containing medicines: products 97 suspension 112 Dabigatran etexilate: updated Safety and Efficacy Issues contraindications 112 Azithromycin: potential risk of QT Idebenone: voluntary withdrawal 113 prolongation 101 Autologous chondrocyte implanta- Osteoporosis treatments: atypical tion approved for cartilage defects 113 femur fracture 102 Vismodegib approved for basal cell Ezogabine: retinal abnormalities carcinoma 114 and blue skin discoloration 103 Lenalidomide: approved for myelo- Incretin mimetics: risk of pancreatitis dysplastic syndromes 114 and pancreatic duct metaplasia 104 Nimodipine oral solution approved Incretin mimetics and GLP-1-based for subarachnoid haemorrhage 114 therapies: pancreatic risks 104 Golimumab approved for ulcerative Belatacept: acute graft rejection 105 colitis 115 Cinacalcet: fatal paediatric hypo- Radium dichloride approved for calcaemia 105 advanced prostate cancer 115 Cilostazol-containing medicines: Erlotinib and diagnostic test restricted use 106 approved for non-small cell Aqueous cream: skin irritation 106 lung cancer 115 Zolpidem products: lower doses Dabrafenib, trametinib and recommended 107 Valproate-related products: risks companion diagnostic test for during pregnancy 108 advanced skin cancer 116 Thalidomide: risk of second primary Cysteamine bitartrate approved for malignancies 108 rare genetic condition 116 Botulinum toxin type B: serious risks 108 Fluticasone furoate and vilanterol Magnesium sulphate during preg- approved for chronic obstructive nancy: teratogenic effects 109 pulmonary disease 117 Varenicline and buproprion: revision Oxycodone with abuse-deterrent to consumer information 109 properties approved 117 Imatinib approved for leukaemia 117 Regulatory Action and News First A1c test labelled for diagnosing Recommended influenza virus diabetes 118 vaccine composition: 2013–2014 Northern hemisphere season 110 The International Pharmacopoeia Counterfeit antimalarial medicines: International Meeting of World detection tool 110 Pharmacopoeias 119 Black triangle for medicines subject to additional monitoring 111 ... (continued) 95 WHO Drug Information Vol. 27, No. 2, 2013 Contents (continued) Recent Publications, Information ATC/DDD Classification and Events ATC/DDD Classification (Temporary) 130 Consortium to test kala-azar treat- ATC/DDD Classification (Final) 132 ments in East Africa 129 New guide to improve procurement International Nonproprietary performance 129 Names Proposed List No. 109 135 WHO Drug Information Digital library e-mail table of contents subscriptions available at: http://www.who.int/druginformation 96 WHO Drug Information Vol. 27, No. 2, 2013 Quality and Safety of Medicines WHO project for the surveillance and monitoring of SSFFC medical products The existence of substandard/spurious/ hospitals, clinics, pharmacies and falsely labelled/falsified and counterfeit licensed entities within the regulated (SSFFC) medical products is not a supply chain — precisely the places new phenomenon, but is increasingly where patients should have the highest recognized by WHO Member States, level of confidence that the medicines regional groups and various international they receive are safe and effective. Every organizations as representing a incident damages confidence in health significant threat to human health. systems, medicines and healthcare professionals. The right to safe, efficacious, quality medicines which are affordable is a Despite this situation, there is no accurate fundamental human right. In some low global assessment of the scope, scale income countries access to healthcare and harm caused by the issue. Much facilities is limited; for those fortunate anecdotal information exists, but there enough to reach a facility they should be is a lack of clear, validated, reliable able to have trust and confidence in the evidence. Some excellent surveys have medicines they receive. Often, this is not been conducted in various parts of the case and with tragic consequences. the world. However, these reports are However, this situation — which was often short-term, restricted to limited once regarded as an issue solely geographic areas and may concentrate affecting low and middle income countries on specific therapeutic categories. They — now impacts all. The vast profits to are frequently used to extrapolate an be made through the high demand and estimate of the global threat which is less large turnover of medical products is a than sound and commonly challenged. powerful driver for those engaged in the Policy makers require reliable evidence manufacture, distribution and supply of upon which to base sound decisions SSFFC medical products. concerning the allocation of finite The rapid increase in connectivity to resources to tackle this damaging issue the Internet has also effectively opened in a proportionate way. up global markets to the distribution of SSFFC medical products. Whilst Surveillance and monitoring enabling access to medicines, it has also In 2010, WHO began to re-examine encouraged a culture of self-diagnosis existing methods and systems of and self-prescribing. Unregulated web collecting data concerning SSFFC sites have been seen in some parts of medical products. A rapid alert system the world as a key source of SSFFC had been developed in the Western products: an issue which is impossible to Pacific Region but was not being regularly regulate effectively and cannot be dealt used. During 2011, two consultative with by one country in isolation. meetings were held in Kiev, Ukraine and Kuala Lumpur, Malaysia. National Worryingly, incidents involving SSFFC regulatory authorities from the respective products are frequently reported from regions were asked to participate and 97 Quality and Safety of Medicines WHO Drug Information Vol. 27, No. 2, 2013 agree on methods to encourage the contacted by WHO within 72 hours. (In reporting of incidents. cases where adverse reactions are reported this is 24 hours). Building upon the good work started in the Western Pacific Region, a new SSFFC data base surveillance and monitoring system was On arrival at WHO, the details contained designed utilizing the submission of a on the Rapid Alert Form are automatically clear, concise and structured Rapid Alert downloaded and will populate the SSFFC Form to encourage a more systematic data base. The system will immediately method of reporting. The objective of identify duplicate reports. For example, the project is to significantly improve it will recognize if the specific batch/lot the quantity and quality of data enabling number of a medical product has been detailed analysis and validation of previously reported and will also match a incidents. range of other details. This allows cross matching of incidents and enables WHO Rapid Alert Form to put Member States in contact with Following further consultation, an elec- each other if dealing with linked incidents. tronic Rapid Alert Form was designed. At WHO, staff within the Quality and This template contains what is con- Safety of Medicines Team will also sidered to be the minimum amount of receive automatic notification of the information for WHO to conduct an initial arrival of a rapid alert. They will conduct risk assessment. Some of the data fields an immediate risk assessment with a are mandatory and failure to complete focus on the current threat to public these fields will prevent the document health and the need to communicate the from being forwarded to WHO. incident to any other countries which may be affected. Sharing of information is only The Rapid Alert Form contains a hidden conducted following consultation with the language recognition code. This enables originator of the report. the form to be completed in one language and automatically translated to English Review and analysis when downloaded into a data base WHO staff will make contact with the retained at WHO Headquarters. The originator of the Rapid Alert either by Rapid Alert Form is currently available telephone or e-mail and ask some in English and a French Version is being additional questions. They will start to tested. It is planned to make Spanish, populate the data base manually with Russian, Arabic and Mandarin versions any further information obtained from available. the originator. The data base contains over 250 fields which can be cross The form is provided as a template searched in any combination, permitting to trained focal points within national detailed analysis. The areas explored regulatory agencies. Once the mandatory in more detail contained within the fields are completed, the document can data base include: suspect product be saved and sent as an attachment via details, laboratory analysis, impact e-mail to [email protected]. Focal points on public health, risk communication, are encouraged to send any photographs, dissemination, method of distribution, laboratory reports or other relevant method of discovery, means and route documents as attachments. of import or export, details of who is responsible for any investigation, details Once sent, the originator will receive an of internet distribution, cost of medical automated message confirming receipt product, photographs of product and free and notifying them that they will be text comment and analysis areas. 98