WHO Drug Information articles from March 2001

WHO Drug Information archives from March 2001

Putting the "partnership" into public-private partnerships. (Personal perspectives).
March 22, 2001... Recent events have brought into focus public-private partnerships with the pharmaceutical industry. The term public-private partnerships is currently receiving unprecedented exposure in international public health. However, there still...

Drug studies in developing countries.
March 22, 2001... Sornchai Looareesuwan (*) One of the common features of developing countries in terms of pharmaceuticals is the lack of ability to generate independently the drugs that they need. These countries have to rely primarily upon products...

Cannabinoids in the management of pain. (Reports on individual drugs).
March 22, 2001... The discovery of cannabinoid [Cbsub.1] and [CB.sub.2] receptors (1, 2) and endogenous agonists (3) for these receptors has renewed the scientific community's interest in their therapeutic value as analgesics and for various conditions,...

Treatment for tuberculosis and standard of care.
March 22, 2001... Tuberculosis caused by strains that are resistant to at least isoniazid and rifampicin is, by convention, termed "multidrug-resistant tuberculosis." (1) A report has recently been published on work in a referral centre in Turkey that has a...

Group procurement of vaccines. (Vaccines and biomedicines).
March 22, 2001... Supply of vaccines world-wide has changed significantly over the past several years. As an example, several countries formerly relying on centralized procurement through UNICEF and WHO are now responsible for purchasing their own vaccines....

The GCC procurement system.
March 22, 2001... This procurement system is being used by six countries within the Gulf Cooperation Council (GCC), either occasionally, or to supply the majority of vaccines. The Kingdom of Saudi Arabia, the largest country in the GCC, and the administrative...

Evaluation of candidate HIV vaccines.
March 22, 2001... WHO has a constitutional responsibility to its Member States to develop norms and standards for vaccines and other biologicals, and regulatory issues are central to this mandate. As part of ongoing collaboration between WHO and UNAIDS to...

Diagnosis of prion diseases soon possible?
March 22, 2001... Since the appearance of bovine spongiform encephalopathy in 1985, the need for an in vivo diagnostic test for prion diseases has become acute (1). In the absence of such a method, extensive slaughtering of cattle is required once an affected...

Implementation of the ICH common technical document. (Current topics).
March 22, 2001... The International Conference on Harmonization (ICH) is a joint initiative involving both regulators and industry as equal partners in the scientific and technical discussions of the testing procedures which are required to ensure and assess...

Monitoring the emergence of antiretroviral resistance. (Current topics).
March 22, 2001... WHO has played a leading role in developing strategies for the surveillance and containment of antimicrobial resistance in bacterial and parasitic diseases. A global resistance monitoring programme is also needed for HIV. In the developed...

Pharmaceutical legislation review.
March 22, 2001... The European Commission has now published a proposal to review pharmaceutical legislation. One objective of the review is to reinforce and improve access to patient oriented and controlled information, including the development of Good...

Argentina takes action against black market pharmaceuticals.
March 22, 2001... Argentina is planning to make urgent changes to its criminal code to combat the country's burgeoning pharmaceuticals black market. This potentially dangerous trade involves drugs which have been stolen, adulterated, counterfeited, and/or...

Pharmacopoeial quality of drugs supplied by nigerian pharmacies.
March 22, 2001... The quality of medicines available in some less-developed countries is inadequate in terms of content of active ingredient. Reasons for the poor quality of drugs include widespread counterfeiting of medicines in less-developed countries,...

Use of placebo in clinical trials.
March 22, 2001... The Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA), is responsible for providing opinions to the European Commission. Council Directive 75/318/EEC specifies that "all...

WHO guidelines on good clinical practice reviewed.
March 22, 2001... WHO has recently convened an informal consultation as a first step in the review of the WHO Guidelines on Good Clinical Practice (GCP) for trials on pharmaceutical products. Participants from Argentina, the European Union, China, Indonesia,...

Harmonization and international drug monitoring. (General information).
March 22, 2001... The foundations of international adverse drug reaction monitoring were established by WHO in 1968 and significant development has been achieved since then by the WHO International Drug Monitoring Programme. This achievement has been possible...

International federation of associations of pharmaceutical physicians.
March 22, 2001... The International Federation of Associations of Pharmaceutical Physicians (IFAPP) is a non-profit organization with twenty-five member associations woridwide. The aim of the Federation is to act as an international forum for organizations of...

New Zealand and Australia: joint medicines regulatory body. (Regulatory and safety matters).
March 22, 2001... The Health Minister of New Zealand has instructed officials to investigate the possibility of a joint trans-Tasman medicines, medical devices and dietary supplements regulatory body. The proposed agency would be responsible for approving...

Bupropion safety information. (Regulatory and safety matters).
March 22, 2001... Canada -- The manufacturer of bupropion, Zyban[R], indicated for smoking cessation treatment in conjunction with behavioural modification, and Wellbutrin[R], indicated for symptomatic relief of depressive illness, has informed health...

Buprapion update. (Regulatory and safety matters).
March 22, 2001... Australia -- Bupropion (Zyban SR[R]) was first marketed in late 2000 as a short-term aid to smoking cessation and has been used by high numbers of patients. Originally developed as an antidepressant, it is a selective inhibitor of the...

Itraconazole and congestive heart failure. (Regulatory and safety matters).
March 22, 2001... United States of America -- The manufacturer of itraconazole capsules, injection and oral solution has revised the labelling as a result of ongoing research, monitoring and evaluation of these products. Itraconazole capsules should not be...

Terbinafine and hepatic failure. (Regulatory and safety matters).
March 22, 2001... United States of America -- The manufacturer of terbinafine (Lamictal[R]) has provided new prescribing information concerning rare cases of hepatic failure, some leading to death or liver transplant. Terbinafine is used for the treatment of...

Paediatric amiodarone labelling changes. (Regulatory and safety matters).
March 22, 2001... United States of America -- Two changes have recently been made to the prescribing information for amiodarone (CordaroneIV[R]). Safety and efficacy of amiodarone IV in the paediatric population have not been established and use in this...

Cerivastatin: marketing discontinued. (Regulatory and safety matters).
March 22, 2001... United States of America -- The manufacturer of cerivastatin sodium (Baycol[R]), approved for the treatment of hyperlipidaemia, has announced its decision to discontinue the marketing and distribution of cerivastatin in the United States (1)....

Phenylpropanolamine withdrawn from market. (Regulatory and safety matters).
March 22, 2001... Canada -- Following a safety assessment, Health Canada has advised that drug products containing phenylpropanolamine are being withdrawn from the market. Following a review of information, it was concluded that use of this ingredient in...

Counterfeit filgrastim. (Regulatory and safety matters).
March 22, 2001... United States of America -- The manufacturer of filgrastim (Neupogen[R]) 300 [micro]g vials in ten-pack boxes has reported the existence of a counterfeit product. Neupogen is primarily used to prevent infection, as manifested by febrile...

Oxycodone: strengthened warning. (Regulatory and safety matters).
March 22, 2001... United States of America -- The Food and Drug Administration has strengthened the warnings and precautions sections in the labelling of oxycodone hydrochloride controlled release tablet (OxyContin[R]), following continued reports of abuse and...

Nesiritide for heart failure. (Regulatory and safety matters).
March 22, 2001... United States of America -- The Food and Drug Administration has approved nesiritide (Natrecor[R]) injection for the treatment of acute congestive heart failure. Nesiritide is a recombinant version of B-type natriuretic peptide, a human...

Oprelvekin: paediatric safety information. (Regulatory and safety matters).
March 22, 2001... United States of America -- The manufacturer of oprelvekin (Neumega[R]) has informed health care professionals of an important change in safety information for paediatric use. No controlled clinical studies have established a safe and...

Peginterferon alfa-2b combined use: new labelling. (Regulatory and safety matters).
March 22, 2001... United States of America -- The Food and Drug Administration has approved a supplemental indication for peginterferon alfa-2b (PEG-Intron[R]) an injectable approved to treat patients with chronic hepatitis C infections to be used in...

Ribavirin for combined use. (Regulatory and safety matters).
March 22, 2001... United States of America -- The Food and Drug Administration has approved ribavirin (Rebetol[R]) capsules, an antiviral used with interferon alfa-2b for the treatment of patients with chronic hepatitis C infection. Also marketed in...

Sleep attacks with pramipexole and ropinirole. (Regulatory and safety matters).
March 22, 2001... Canada -- Recent adverse drug reaction reports associated with pramipexole (Mirapex[R]) and ropinirole (Requip[R]) have included a higher proportion of sleep disorder cases. Sleep-related disorders constituted 26 of 57 reports and 16 out of...

Rosiglitazone-associated hepatic and cardiovascular events.
March 22, 2001... Canada -- Between March 2000 and February 2001, 166 rosiglitazone (Avandia[R])-associated adverse drug reactions were reported to the Canadian Adverse Drug Reaction Monitoring Program (CADRMP). Of these, 38 were classified as serious; with 20...

Clarithromycin: labelling change. (Regulatory and safety matters).
March 22, 2001... Japan -- The Ministry of Health, Labour and Welfare (MHLW) has called for hepatic dysfunction, jaundice and rhabdomyolysis to be included in the 'Clinically significant adverse reactions' section of clarithromycin-containing products...

Herbal OTC remedy and hepatic dysfunction. (Regulatory and safety matters).
March 22, 2001... Japan -- Three cases of hepatic dysfunction have been reported during treatment with the over-the-counter product Seirogan[R], which contains glycyrrhizin, creosote, gambir, phellodendron bark and citrus unshiu peel. The product is indicated...

Antipsychotics and high prolactin. (Regulatory and safety matters).
March 22, 2001... New Zealand -- The Medicines and Medical Devices Safety Authority (Medsafe) recommends reducing the dosage, or changing to an atypical antipsychotic agent, when patients receiving typical antipsychotics or risperidone (an atypical...

Sildenafil: not for use with nitrates. (Regulatory and safety matters).
March 22, 2001... New Zealand -- The Medicines and Medical Devices Safety Authority (Medsafe) has emphasized the importance of asking patients about sildenafil (Viagra[R]) use before any formulation of nitrates is administered, and that patients prescribed...

Propofol, heart failure and high dosages. (Regulatory and safety matters).
March 22, 2001... Norway -- The Norwegian Medical Products Agency has announced several recommendations in response to reports of heart failure in association with high dosages of propofol. * Careful monitoring is necessary when adults receive propofol...

Bupropion and seizures. (Regulatory and safety matters).
March 22, 2001... Singapore -- The Drug Monitoring Unit has received 3 reports of seizures with bupropion/amfebutamone (Zyban[R]) in recipients who had not consumed alcohol and had no history of seizure disorders. The men, aged between 37 and 41 years, were...

Neurotoxicity with aciclovir and valaciclovir. (Regulatory and safety matters).
March 22, 2001... Sweden -- Reports of central nervous system disorders, including confusion, hallucinations, psychosis, agitation, seizures, and impaired coordination, have been made to the Swedish adverse drug reactions data base at the Medicines Products...

Revised labelling for levocarnitine. (Regulatory and safety matters).
March 22, 2001... United States of America -- A letter has been issued to health care professionals by the manufacturer of levocarnitine (Carnitori[R]), to emphasize that only IV preparations of this drug are approved for use in patients with end-stage renal...

Avoid trastuzumab and anthracyclines. (Regulatory and safety matters).
March 22, 2001... European Union -- The European Agency for the Evaluation of Medicinal Products (EMEA) has issued a public statement advising that anthracycline therapy should be avoided for 22 weeks following discontinuation of trastuzumab (Herceptin[R])....

Resurgence of sleeping sickness. (Essential drugs).
March 22, 2001... Human African trypanosomiasis, known as sleeping sickness, is a vector-borne parasitic disease. The parasites concerned are protozoa transmitted to humans by tsetse flies found in vegetation by rivers and lakes, gallery-forests and vast...

GMP training modules. (Recent publications and sources of information).
March 22, 2001... Lack of good manufacturing practices (GMP) has been identified as a major obstacle to the production of locally manufactured medicines of assured quality. In 1998, with financial assistance from the Government of Japan, WHO initiated a...

Current challenges in pharmacovigilance. (Recent publications and sources of information).
March 22, 2001... In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines, consensus is needed on standards for many difficult aspects of day-today pharmacovigilance that continue to pose...

WHO reproductive health library. (Recent publications and sources of information).
March 22, 2001... The WHO Reproductive Health Library (RHL) project was initiated in April 1996. The project is a collaborative effort between WHO, the Cochrane Library and the UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research...

Management of sexually transmitted infections. (Recent publications and sources of information).
March 22, 2001... Sexually transmitted infections remain a public health problem of major significance in most parts of the world, and failure to diagnose and treat STIs at an early stage may lead to serious complications involving unnecessary individual and...

Safe blood starts with me. (Recent publications and sources of information).
March 22, 2001... The Blood Transfusion Safety Team at WHO is pleased to make available -- free of charge -- a CD-ROM containing facts, figures and photos on the importance of safe blood. This material, is an excellent educational tool for schools or health...

Improved access to biomedical journals. (Recent publications and sources of information).
March 22, 2001... The World Health Organization and the world's six biggest medical journal publishers have announced a new initiative which will enable close to one hundred developing countries gain access to vital scientific information that they otherwise...

Global information flow.
March 22, 2001... According to the authors of an important article published in the Lancet last year, information flow could be one of the most important factors for improving health and development in resource-poor settings. However, it would seem that until...

First asian course in problem-based pharmacotherapy teaching.
March 22, 2001... The first Asian training course on problem-based pharmacotherapy teaching will be held from 19-28 October 2001 (inclusive) in Manila, Philippine. It is being organized jointly by the Philippine Society of Experimental and Clinical...

International nonproprietary names for pharmaceutical substances (INN).
March 22, 2001... 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...