ОБЩЕРОССИЙСКАЯ ОБЩЕСТВЕННАЯ ОРГАНИЗАЦИЯ ИНВАЛИДОВ-БОЛЬНЫХ РАССЕЯННЫМ СКЛЕРОЗОМ

EMEA Concludes New Advice to Doctors and Patients for Tysabri (natalizumab) Needed

www.drugs.com

 

LONDON, March 20, 2008-The European Medicines Agency (EMEA) has concluded that warnings about liver injury should be added to the product information for Tysabri (natalizumab).

Tysabri is used to treat relapsing-remitting multiple sclerosis (MS) in patients with high disease activity despite treatment with a beta-interferon or whose disease is severe and evolving rapidly.

Following a review of reports of liver injury in patients treated with Tysabri, the EMEA’s Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to update the product information for Tysabri to warn patients and prescribers that liver injury may occur.

Doctors should monitor the liver function of patients receiving Tysabri. Patients who observe any signs of liver injury, such as yellowing of the skin or the whites of the eyes, or unusual darkening of the urine should see their doctor.

The CHMP has requested that Elan, the marketing authorisation holder for Tysabri, submits a variation to the marketing authorisation to implement these changes.

As with all medicinal products, the EMEA will continue to monitor Tysabri closely to ensure that the benefits of the medicine continue to outweigh its risks.

Minister Golikova opposes fragmentation of the Ministry of Health and Social Development

14:41 27.03.2008

Minister of Health and Social Development of Russia Tatiana Golikova deems it inexpedient to fragment the office she is heading into two departments. She made a point of it in her statement when answering journalists’ questions today following a meeting of the government.

She pointed out that, in her opinion, once the two departments merged in the Ministry of Health and Social Development in 2004, the merger ‘was not quite expedient’.

In addition, Tatiana Golikova said that, by that time, the renewed ministry had faced rather wide-ranging objectives. ‘Most likely, implementation of these objectives would have been more effective, if a different decision had been made then in 2004’, she stressed.

However, according to the Minister, the social and healthcare functions at the Ministry are associated today so much that separation of the office will be harmful only. ‘Any fragmentation will prove inefficient in terms of further management of the process. Cutting [the office] in parts means cutting the responsibility for performing the provisions in documents as well as what has already been achieved’, said Golikova. As an example, she addressed the implementation of demographic policy, where the social policy is closely associated with healthcare. ‘In this respect, I believe, the united ministry should be preserved to be effective’, Tatiana Golikova concluded.

http://www.rbc.ru

 

TALKING OF PHARMACOLOGICAL SUPPORT PROBLEMS AGAIN

Solominka, №4(24), April, 2008 

Starting 2008, 60 thousand Russians suffering from diseases, being the most expensive for treatment, shall receive medicines to keep up their lives at the expense of the federal budget. The situation of medicinal support for seriously ill patients has really improved. However, the words of the authorities are hard to swallow in practice. 

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ALLEVIATION FOR THE DISABLED

 

A few months ago, there were reports (http://ms2002.ru) that raised the issue of the burden disabled people experienced while getting re-examined for their disability status. It might be shocking but even amputees and people with progressive diseases, e.g. multiple sclerosis, had to be formally confirmed as disabled every year. The Russian President heard the problem firsthand and gave an instruction to the Health Minister to intervene in the situation. Today, the Ministry, where there is an Adviser from the All-Russian MS Society, has taken drastic measures. (Translator’s note) 

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FEDERAL SERVICE FOR HEALTH CONTROL MAKES AN AGREEMENT WITH MEDICAL INSURERS

 

THE FEDERAL SERVICE FOR HEALTH CONTROL IN THE RF (ROSZDRAVNADZOR) MADE AN AGREEMENT WITH THE INTERREGIONAL UNION OF MEDICAL INSURERS

14:21 26.03.2008

Starting 2006, Roszdravnadzor has actively been attracting a variety of state, public, and trade organizations to tackle certain issues in a specific area of activities. Over 50 agreements on cooperation have been made so far. The latest agreement was signed on March 24th this year. Chief of the Federal Service for Health Control Nikolay Yurgel and Director General of the Interregional Union of Medical Insurers (IUMI) signed the agreement on cooperation on legal regulations in the area of medical assistance quality enhancement for population.

According to the Roszdravnadzor head, the negotiated terms will enable organizing the on-line information exchange on common trends of activities, coordinating work plans and boosting the efficiency of collaboration between structural sections and subordinate institutions of the Federal Service and the IUMI.

“Roszdravnadzor , - Nikolay Yurgel pointed out, - is able to attract IUMI representatives as work group members or experts to the development of regulatory documents and the order of controlling activities, to developing relevant solutions to promote insurance principles within the healthcare system and create competitive environment in the medical services market.”

(Roszdravnadzor Press Service)