[Parution du Volume 21 N°1 du "WHO DRUG INFORMATION", une référence sur les
pratiques thérapeutiques et les médicaments.
Disponible seulement en anglais.CB]
WHO DRUG INFORMATION highlights topics of current concern, recent regulatory
decisions and standard-setting activities, with a focus on the processes
linking regulatory activity to therapeutic practice. It presents selected
contributions portraying a variety of viewpoints from different disciplines
and pharmaceutical sciences. WHO DRUG INFORMATION can be viewed at:
http://www.who.int/druginformation
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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