WHO DRUG INFORMATION, Volume 21 Number 1
The first issue of WHO Drug Information for 2007 opens with an overview of recent developments in establishing quality guidelines within the International Conference on Harmonization (ICH) framework. A lead article on access to pain medication focuses on the difficulties of ensuring the availability of medicines on the controlled substances lists, and is followed by a description of the valuable work and progress being made in Uganda to alleviate the suffering of HIV and cancer patients through administration of oral morphine. Sharing the spotlight in this issue is an authored study on the use of a new method - concordance - to improve patient adherence to medicines.
Topics of Current Interest describe latest developments in biological quality and safety, with a list of new standards endorsed by the WHO Expert Committee. WHO has also launched a new programme on good governance aimed to improve transparency within regulatory authorities.
Extensive information is provided in the section on Safety and Efficacy Issues concerning the latest signals, reports of adverse drug reactions, and labeling changes.
The issue is completed with the latest ATC/DDD Classification lists, draft proposals for oseltamivir and lumefantrine and dissolution tests within International Pharmacopoeia activities. Summaries are included of Recent Publications, Information and Events considered of interest to readers. This issue concludes with Recommended INN List 57.
Table of Contents
Quality Assurance International Conference on Harmonization (ICH) 3 New developments in quality 3
Safety and Efficacy Issues Rotavirus vaccine and intussusception 8 Zolpidem and bizarre sleep related effects 8 Rituximab: life-threatening brain infection 9 Methadone for pain: cardiac and respiratory changes 9 Levofloxacin: dysglycemia and liver disorder 10 Domperidone: heart rate and rhythm disorders 11 Complications with use of bone cement 12 Infant deaths associated with cough and cold medications 13 Ranibizumab and stroke 14 Increased risk of fractures: antiepileptic medicines 14 Vasomist® and nephrogenic systemic fibrosis 15
Access to medicines The challenges of ensuring pain medication 16 Import and safe distribution of oral morphine for pain relief in Uganda 18 Topics of Current Interest Developments in biological quality, safety and efficacy 21 Transparency in Medicines Management 24 WHO Programme on Good Governance for Medicines 24
Rational Use of Medicines Use of concordance to improve patient adherence 27 Influencing health professionals for better health outcomes 27
ATC/DDD Classification ATC/DDD Classification (Temporary) 33 ATC/DDD Classification (Final) 36
International Pharmacopoeia Draft proposal: oseltamivir phosphate 38 Draft proposal: lumefantrine 43 Dissolution tests 47
Recent Publications, Information and Events International Pharmacopoeia: fourth edition 51 Draft report: Specifications for Pharmaceutical Preparations 51 User guide for micro, small and medium sized enterprises 52
Recommended International Nonproprietary Names: List 57 53
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