WHO Drug Information articles from September 2004

WHO Drug Information archives from September 2004

Cost containment and generic substitution.(Drug Management)
September 22, 2004... Expenditure on medicines accounts for a major proportion of public health costs and governments increasinlgly focus on ways to reduce the burden on public spending. Overall, generic drugs are substantially less expensive than branded products...

Generic substitution in Finland.(Drug Management)
September 22, 2004... Generic substitution aims at promoting cost-effective medical treatment. Savings are made both by actually replacing products with less expensive alternatives, and by promoting tougher price competition between pharmaceutical companies....

Australian experience with Pneumococcal conjugate vaccine.(Safety and Efficacy Issues)
September 22, 2004... Pneumococcal conjugate vaccine was registered in February 2001 for active immunization of infants and children from 6 weeks to 9 years of age against invasive disease, pneumonia and otitis media caused by Streptococcus pneumoniae. From surveys...

Overdose and tricyclic antidepressants.(Safety and Efficacy Issues)
September 22, 2004... The total quantity in milligrams of tricyclic antidepressant that can be obtained by patients at risk of suicide is a concern. Particularly, high-dose presentations of tricyclic antidepressants have been associated with patient deaths from...

Terbinafine and blood dyscrasias.(Safety and Efficacy Issues)
September 22, 2004... Oral terbinafine is indicated for onychomycosis caused by dermatophyte fungi and for tinea unresponsive to topical therapy. Haematological reactions, notably agranulocytosis, neutropenia or pancytopenia, are rare adverse effects of systemic...

Cholinesterase inhibitors and cardiac arrhythmias.(Safety and Efficacy Issues)
September 22, 2004... Cholinesterase inhibitors such as donepezil, rivastigmine and galantamine are being used increasingly in the treatment of Alzheimer's disease. The product information for all three drugs notes that increased cholinergic activity may have vagal...

Lamotrigine: hormonal contraceptives decrease serum levels.(Safety and Efficacy Issues)
September 22, 2004... Canada -- The manufacturer of lamotrigine (Lamictal[R]), an anti-epileptic, has announced important new safety information concerning concomitant use of hormonal contraceptives with lamotrigine, which may significantly decrease serum...

Transdermal fentanyl and respiratory arrest in adolescents.(Safety and Efficacy Issues)
September 22, 2004... Health Canada has received two case reports of death suspected of being associated with the use of transdermal fentanyl system (Duragesic[R]) prescribed off-label to adolescents. In one case, a 15-year-old girl was prescribed Duragesic 25[R]...

Infliximab and etanercept: serious infections and tuberculosis.(Safety and Efficacy Issues)
September 22, 2004... Tumour necrosis factor-alpha (TNF-[alpha]) is a pro-inflammatory cytokine synthesized in response to infectious or inflammatory stimuli (1). TNF-[alpha] antagonists have been shown to be effective in the treatment of signs and symptoms of...

Medication error alert.(Safety and Efficacy Issues)
September 22, 2004... Manufacturers have recently been made aware of several reports of medication errors involving confusion between Reminyl[R] (galantamine hydrobromide), a drug approved for the treatment of mild to moderate dementia of the Alzheimer's type, and...

International standard for genetic testing.(Current Topics)
September 22, 2004... The first international standard for a human genetic test has been approved by the WHO Expert Committee on Biological Standardization. Use of the standard will help to improve the accuracy and quality of laboratory results for a genetic test...

Selective reporting and clinical trial registration.(Current Topics)
September 22, 2004... A statement recently appeared in the New England Journal of Medicine by members of the International Committee of Medical Journal Editors concerning the proposed policy on acceptance of publications and clinical trial registration. The text is...

Trials registration policy.(Current Topics)
September 22, 2004... The International Committee of Medical Journal Editors (ICMJE) proposes comprehensive trials registration as a solution to the problem of selective awareness and announces that all ICMJE member journals will adopt a trials-registration policy...

National Library of Medicine trials registration.(Current Topics)
September 22, 2004... As a consequence of the International Committee of Medical Journal Editors (ICMJE) statement on trials registration, concerns have been raised that ClinicalTrials.gov is the only existing registry that currently fulfils the ICMJE specified...

Antidepressants and suicidality in children and adolescents.(Regulatory and Safety Action)
September 22, 2004... United States of America--the Food and Drug Administration (FDA) has directed manufacturers of all antidepressant drugs to revise the labelling for their products to include a boxed warning and expanded warning statements that alert health care...

Withdrawal of rofecoxib.(Regulatory and Safety Action)
September 22, 2004... United States of America--Rofecoxib (Vioxx[R]), a prescription COX-2 selective nonsteroidal anti-inflammatory drug (NSAID), has been voluntarily withdrawn from the market by the manufacturer due to safety concerns. Rofecoxib was approved by the...

Regulations for COX-2 inhibitors.(Regulatory and Safety Action)
September 22, 2004... Turkey -- The manufacturer of Celebrex[R] has voluntarily withdrawn its product from the Turkish market on 19 November 2004 after the Turkish Ministry of Health asked for new warnings to be added to the package insert and on the outer package....

Southern hemisphere influenza vaccines 2005.(Regulatory and Safety Action)
September 22, 2004... World Health Organization--The following influenza virus vaccine composition has been recommended for the forthcoming winter in the southern hemisphere. * an A/New Caledonia/20/99(H1N1)-like virus; * an A/Wellington/1/2004(H3N2)-like...

European regulation for paediatric medicinal products.(Regulatory and Safety Action)
September 22, 2004... European Union--Within Europe, more than half of medicines used to treat children have not been tested or authorized for such use. The general lack of information and appropriate formulations for administering medicines to children may well...

Ephedrine and pseudoephedrine to become controlled drugs.(Regulatory and Safety Action)
September 22, 2004... New Zealand -- From 15 October 2004, all ephedrine and pseudoephedrine containing products will become controlled drugs. This means that ephedrine and pseudoephedrine will be controlled under the Misuse of Drugs Act 1975 and the Misuse of Drugs...

Epoetin alfa and blood clot formation in cancer patients.(Regulatory and Safety Action)
September 22, 2004... Canada -- The manufacturer of epoetin alfa (Eprex[R]), authorized for use in Canada since 1995 for the treatment of anaemia in patients with cancer, has informed health care professionals of important new safety information. Results of...

Mifepristone: labelling changes.(Regulatory and Safety Action)
September 22, 2004... United States of America -- The Food and Drug Administration has announced new safety changes to the labelling of mifepristone (Mifeprex[R]) approved in 2000 for the termination of early pregnancy, defined as 49 days or less (1). Up to...

TNF-blocking agents and serious infections.(Regulatory and Safety Action)
September 22, 2004... United States of America -- The manufacturer of adalimumab (Humira[R]) has communicated new warnings of hypersensitivity reactions and haematologic events, which have been added to the prescribing information. Adalimumab is a biological...

Long-term use of Depo-Provera[R] and bone density loss.(Regulatory and Safety Action)
September 22, 2004... United States of America -- The Food and Drug Administration (FDA) has announced that a warning will be added to the labelling of Depo-Provera[R] Contraceptive Injection, an established injectable drug approved for use in women to prevent...

Duloxetine approved for neuropathic pain associated with diabetes.(Regulatory and Safety Action)
September 22, 2004... United States of America -- The Food and Drug Administration (FDA) has announced the approval of duloxetine hydrochloride (Cymbalta[R]) capsules for the management of pain associated with diabetic peripheral neuropathy. This is the first drug...

Aripiprazole approved for acute bipolar mania.(Regulatory and Safety Action)
September 22, 2004... United States of America -- The Food and Drug Administration (FDA) has approved aripiprazole (Abilify[R]) for the treatment of acute bipolar mania, including manic and mixed episodes associated with bipolar disorder. The approval is based...

3 by 5 strategy: improving access to paediatric HIV medicines.(HIV Medicines)
September 22, 2004... Antiretroviral (ARV) treatment has became increasingly available over the last decade, transforming HIV disease into a chronic condition, but the widening treatment gap between HIV-infected patients in resource-rich and resource-poor settings...

WHO prequalification: implications of de-listing.(HIV Medicines)
September 22, 2004... The prequalification project was set up in 2001 as a service provided by WHO to facilitate access to medicines used in the treatment of HIV/AIDS, malaria and tuberculosis, that meet unified standards of quality, safety and efficacy. From the...

Combining TB and HIV treatment to save lives.(HIV Medicines)
September 22, 2004... Expanding access to tuberculosis treatment, combined with introducing HIV testing and antiretroviral (ARV) delivery into TB programmes, could save the lives of as many as 500 000 Africans living with HIV every year and is one of the most...

Three new quality assurance guidelines endorsed by WHO Expert Committee.(Recent Publications and Sources of Information)
September 22, 2004... The work of the Expert Committee on Specifications for Pharmaceutical Preparations has a direct impact on a number of WHO priorities and policy objectives related to quality assurance, including the 3 by 5 Strategy, access to essential...

WHO medicines bookshelf.(Recent Publications and Sources of Information)
September 22, 2004... The latest version of the WHO Medicines Bookshelf CD-ROM contains over 350 medicines-related publications, in English, French and Spanish, taken primarily from materials published by the Department of Essential Drugs and Medicines Policy (EDM)....

International conference on improving use of medicines.(Recent Publications and Sources of Information)
September 22, 2004... The goal of improving global access to medicines cannot be fulfilled without a corresponding improvement in use. This is a key message from the second International Conference on Improving Use of Medicines (ICIUM 2004), held 30 March--2 April...

International network on HIV/AIDS for pharmacists.(Recent Publications and Sources of Information)
September 22, 2004... The newly launched International Network for Pharmacists on HIV/AIDS is an initiative created by the International Pharmaceutical Federation (FIP). The Network aims to provide a platform for discussion and information sharing among...

Managing pharmaceuticals internationally.(Recent Publications and Sources of Information)
September 22, 2004... The availability of essential drugs is a key determinant of public health in many countries and addressing the inequalities in drug supply is a major challenge. Managing Pharmaceuticals in international Health aims to provide an introduction to...

New brochure on adverse reaction reporting.(Recent Publications and Sources of Information)
September 22, 2004... Health Canada has developed a new brochure on adverse reaction reporting by health care professionals and consumers. The brochure covers what and when to report, how to submit a report, and how to access safety information on marketed health...

International chemical reference substances for malaria.(Recent Publications and Sources of Information)
September 22, 2004... Many developing countries are facing a growing problem of substandard and counterfeit medicines entering their markets. To enable governments to confront this issue by testing the quality of essential medicines, WHO has established a collection...

New physician guidelines on commercial relationships.(Recent Publications and Sources of Information)
September 22, 2004... The World Medical Association (WMA) has issued guidelines for physicians on how to handle relationships with the commercial sector, such as gifts, conference attendance, research and affiliations. The move is aimed to improve transparency of...

COHRED and research into action.(Recent Publications and Sources of Information)
September 22, 2004... The Council on Health Research for Development (COHRED) is an international nongovernmental organization working towards enabling countries to set up and use health research to foster health, equity in health, and development. A special...

New antimicrobial resistance website for the public.(Recent Publications and Sources of Information)
September 22, 2004... The United Kingdom National Electronic Library of Infection (NELl) has set up an antimicrobial resistance website at http://www.antibiotic resistance.org.uk The site has been developed in response to current concerns about antimicrobial...

Evaluation of medicinal products in children.(Recent Publications and Sources of Information)
September 22, 2004... An increase in the number of studies performed in children is expected as a consequence of the new European regulation on medicinal products in children. The actors of drug evaluation in children should be prepared for this, and a teaching...

Procurement of medicines in HIV.(Recent Publications and Sources of Information)
September 22, 2004... The World Bank's Implementation Acceleration Team was created to improve inadequate procedures and practices for a faster and more flexible intervention. A Decision Maker's Guide to the Procurement of Medicines and Related Supplies, represents...

Therapeutic guidelines: dermatology.(Recent Publications and Sources of Information)
September 22, 2004... The Therapeutic Guidelines are written for prescribers and other health professionals, They are independent, peer reviewed, regularly updated and provide independent, practical and succinct therapeutic information. All Therapeutic Guideline...

International pharmacopoeia available on CD-ROM.(Recent Publications and Sources of Information)
September 22, 2004... The International Pharmacopoeia comprises a collection of recommended procedures for analysis and specifications for the determination of pharmaceutical substances, excipients, and dosage forms that are intended to serve as source material for...

Safety monitoring of herbal medicines.(Recent Publications and Sources of Information)
September 22, 2004... Many people in the world take herbal medicines for their health care and safety is a fundamental principle in the provision of herbal products. The WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems identify...

Medicinal plant guidelines translated.(Recent Publications and Sources of Information)
September 22, 2004... The WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants are an important initial step to ensuring provision of good quality, safe herbal medicines and ecologically sound cultivation practices for future...

The International Pharmacopoeia--monographs for antiretrovirals.(Consultation Documents)
September 22, 2004... Within the framework of the Procurement, Quality and Sourcing Project for HIV, Tuberculosis and Malaria (http://www.who.int/prequal), The International Pharmacopoea is collaborating with manufacturers, independent analytical drug quality...

The International Pharmacopoeia: monographs for antiretrovirals.(Consultation Documents)
September 22, 2004... Within the framework of the Procurement, Quality and Sourcing Project for HIV, Tuberculosis and Malaria (http:I/www.who.int/prequal), The InternationalPharmacopoeia is collaborating with manufacturers, independent analytical drug quality...

The International Pharmacopoeia: monographs for antiretrovirals: ritonavirum (1st draft) ritonavir.(Consultation Document)
September 22, 2004... Within the framework of the Procurement, Quality and Sourcing Project for HIV, Tuberculosis and Malaria (http://www.who.int/prequal), The International Pharmacopoeia is collaborating with manufacturers, independent analytical drug quality...

The International Pharmacopoeia: monographs for tuberculosis medicines: rifampicin, isoniazid and pyrazinamide tablets (1st draft).(Consultation Document)
September 22, 2004... Within the framework of the Procurement, Quality and Sourcing Project for HIV, Tuberculosis and Malaria (http://www.who.int/prequal), The International Pharmacopoeiais collaborating with manufacturers, independent analytical drug quality...

The International Pharmacopoeia: monographs for tuberculosis medicines: isoniazid and ethambutol hydrochloride tablets (1st draft).(Consultation Document)
September 22, 2004... Within the framework of the Procurement, Quality and Sourcing Project for HIV, Tuberculosis and Malaria (http://www.who.int/prequal), The International Pharmacopoeia is collaborating with manufacturers, independent analytical drug quality...

The International Pharmacopoeia: monographs for tuberculosis medicines: rifampicin, isoniazid, pyrazinamide and ethambutol hydrochloride tablets (1st draft).(Consultation Document)
September 22, 2004... Within the framework of the Procurement, Quality and Sourcing Project for HIV, Tuberculosis and Malaria (http://www.who.int/prequal), The International Phafmacopoeia is collaborating with manufacturers, independent analytical drug quality...

The International Pharmacopoeia: monographs for tuberculosis medicines: rifampicin tablets (1st draft).(Consultation Document)
September 22, 2004... Within the framework of the Procurement, Quality and Sourcing Project for HIV, Tuberculosis and Malaria (http://www.who.int/prequal), The International Pharmacopoeia is collaborating with manufacturers, independent analytical drug quality...

The International Pharmacopoeia: monographs for tuberculosis medicines: rifampicin and isoniazid tablets (1st draft).(Consultation Documents)
September 22, 2004... Within the framework of the Procurement, Quality and Sourcing Project for HIV, Tuberculosis and Malaria (http://www.who.int/prequal), The International Pharmacopoeia is collaborating with manufacturers, independent analytical drug quality...

International Nonproprietary Names for Pharmaceutical Substances (INN)
September 22, 2004... Notice is hereby given that, in accordance with article 3 of the Procedure for the Selection of Recommended International Nonproprietary Names for Pharmaceutical Substances. the names given in the list on the following pages are under...