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Issue 14 - 3 September 2004 The Department of Transport is drawing up guidelines on driving under the influence of prescription drugs and narcotics, which will warn patients that long-term medication and OTC remedies for hay fever may impair drivers' performance as often as alcohol. The guidelines would replace the information disseminated 10 years ago when many now commonly used remedies were not yet available. The Office of Fair Trading (OFT) is to investigate Novartis Pharmaceuticals over a suspected breach of the Competition Act. This follows complaints that Novartis had been “talking down” clozapine newcomer Denzapine, which is marketed by Denfleet as the sole competitor to Novartis’s Clozaril brand but which is underpinned by a discount scheme which can as much as halve the list price of the brand. Denfleet has said that in a trust treating 450 patients a year with the drug this could mean savings of £650,000 a year. Novartis has promised to co-operate fully and has invited the OFT to inspect its business. Recent publications NOTE: This guideline is applicable to both Human and Veterinary medicinal products. It supersedes the guideline "Requirements in relation to active substances" 3AQ6a, which was published in Volume 3A and referred to in Volume 7B. A section has been specifically created to help those operating within the herbal medicine sector to understand and comply with the forthcoming Traditional Herbal Medicines Registration Scheme (THMRS), as required by Directive 2004/24/EC on Traditional Herbal Medicinal Products. The 119th session of the European Pharmacopoeia CommissionThe 119th session meeting of the European Pharmacopoeia Commission was held in Strasbourg on 15-17 June 2004. In total, just under 30 monographs and texts were adopted along with 50 revisions. The most extensive technical change was the adoption of the new internationally harmonised test 2.9.40 ‘Uniformity of dosage units’ and incorporation into all relevant pharmaceutical form monographs. Currently, the Quality Working Party (QWP) is evaluating how and when the new test should replace the existing tests. Marketing authorisations Generic pravastatin available in UK Generic pravastatin is now available in the UK as 10mg, 20mg and 40mg tablets from Almus, Ivax and Alpharma. A new initiative to encourage the development of paediatric medicines has been announced by Health Minister, Lord Warner. These proposals will encourage the pharmaceutical industry to research and develop medicines geared towards the needs of children. They will also ensure prescribers will have better information about the impact of medicines on children. The MHRA have also developed a new section on medicines for children, which is available on the Medicines section of their site. MHRA issues drug alert on counterfeit tadalafil (Cialis™) 20mg tablets in UK The MHRA is recalling two lots of tadalafil (Cialis™) 20mg tablets after discovery of counterfeit material in the UK supply chain. The batches involved are a carton containing a blister of 4 tablets, lot number A03140, exp 06/2006 and another batch, lot number A041410, with unknown expiry date or pack size. New Products 1. Co-Diovan (valsartan and hydrochlorothiazide fixed dose combination 160/12.5mg and 160/25mg) Tablets by Novartis. 2. Lyrica (pregabalin) 25, 50, 75,100, 150, 200 and 300mg capsules by Pfizer. 3. New HIV drug fosamprenavir (Telzir™) lhas been aunched in UK. According to GSK, Telzir is the only protease inhibitor to offer once or twice daily dosing with no food or water restrictions. Patent expiry Halofantrine Sept 2004 Propiverine Sept 2004 Clarithromycin Nov 2004 Epoetin alpha/beta Dec 2004 Interferon gamma Dec 2004 Lodoxamide Dec 2004 Health policy review - the pharmaceutical industry Many people criticise the pharmaceutical industry for making excessive profits, however healthcare systems also rely on it to provide new and better medicines to treat or stave off disease. Those countries that have significant pharmaceutical industry presence also benefit from the money these companies bring in. This review looks at some of the major components of the debate, and the author tries to clarify some of the issues involved. It is written by a US author in a US journal, so inevitably concentrates on the situation there, nevertheless many of the issues have a global impact making it of broader interest. New Engl J Med 2004; 351: 927-32 - New England Journal of Medicine website ======================== Did you know ... Talkback If you have any comments or questions, please contact the editor at Alliance ERAS.
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