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Tuesday, 12 January 2010 10:42 GMT
Rheumatologists worried over injectable corticosteroid stock shortages in France
by Romain Loury
PARIS, Jan 12 (APM) - Community stock shortages of four injectable corticosteroid products, used in intra-articular infiltration, are causing concern to the national rheumatologists' union (SNMR), its chairman Vincent Diebolt told APM on Monday.
In a letter to health minister Roselyne Bachelot at the end of December, Diebolt drew attention to stock shortages of two Sanofi-Aventis products, Altim (cortivazol) and Hydrocortancyl (prednisolone acetate), Daiichi Sankyo's Hexatrione (triamcinolone hexacetonide and Merck group member Schering-Plough's Diprostene (betamethasone).
Shortages of the two Sanofi products have been felt since October, the Daiichi Sankyo product since November and the Schering-Plough product since December.
Diebolt told APM in an interview: "As chairman of the SNMR, I have to make sure patients can access care and that rheumatologists can treat them satisfactorily." Diebolt is a rheumatologist with a practice in Obernai (Bas-Rhin).
He added that the shortage represents a public health problem and expressed surprise that the minister has not even acknowledged his letter, let alone replied to it.
Contacted by APM, Fabienne Bartoli, deputy director general of the French health products safety agency (Afssaps), said that an initial stock outage of Altim in October, because of a production problem, meant the other products were oversubscribed.
Bartoli said that so far the stock shortages apply to pharmacies only; hospitals receive products on a quota basis.
A meeting with Sanofi-Aventis officials was scheduled at Afssaps on Monday evening, in the presence of executives of the French society for Rheumatology (SFR). Contacted by APM, neither Sanofi nor SFR had any comments they wished to make on Monday.
Bartoli said that if it were not possible to solve the problem immediately, Afssaps would set out a priority process for the products together with rheumatology representatives, including SFR representatives.
A spokesperson for the French arm of Schering-Plough told APM the company was doing its best to meet demand. The company is expecting supplies in January but they will probably fall short of the requirements.
The spokesperson said that the Diprostene shortages affected pharmacies only, but she warned that hospitals could be affected if too many patients go there (community rheumatologists can send their patients with a prescription for an injectable corticosteroid to a hospital pharmacy that will dispense the product to them).
NEW HEXATRIONE SUPPLIER
While it seems that the Diprostene and Hydrocortancyl shortages are a consequence of the shortage of Altim, the shortage of Hexatrione is the result of a different problem. Hexatrione is the only product, out of the four, indicated in juvenile idiopathic arthritis.
In an interview with APM, a Daiichi Sankyo France spokesperson said there has been a change in supplier.
The product used to be supplied by Axcell Biotechnologies, a company in Lyon that produces a vaccine to protect against leptospirosis that was bought by Imaxio, early in 2009. The product will now by manufactured by IDD-Tech, another company in the Rhone region.
The spokesperson said Daiichi Sankyo had prepared for the change in supplier but that the production set up took longer than expected. She said the validation process had posed problems.
According to an Afssaps regulatory affairs official, the agency received a file on the site transfer process on Dec 24, but it will take three months to process the file. Daiichi Sankyo says it can supply the product as soon as the green light is given.
Consequently, the Daiichi Sankyo spokesperson said the shortage would last until April. The shortage affects pharmacies, but not hospitals.
When asked to provide details on the product shortages, Diebolt said that as soon as he learned of the Altim shortage, he prepared two months' stock, and he issues the required product to a patient, who re-supplies the rheumatologist if a pharmacy can make good the prescription.
Diebolt said his stock was getting very low and would run out in 10 days' time. "Then I'll have to put my patients on oral corticosteroids," he said. However, oral corticosteroids have side effects, with cardiovascular consequences.
rl/aki/nh
[17739] 12/01/2010 10:42 GMT - INDUSTRY
PARIS, Jan 12 (APM) - Community stock shortages of four injectable corticosteroid products, used in intra-articular infiltration, are causing concern to the national rheumatologists' union (SNMR), its chairman Vincent Diebolt told APM on Monday.
In a letter to health minister Roselyne Bachelot at the end of December, Diebolt drew attention to stock shortages of two Sanofi-Aventis products, Altim (cortivazol) and Hydrocortancyl (prednisolone acetate), Daiichi Sankyo's Hexatrione (triamcinolone hexacetonide and Merck group member Schering-Plough's Diprostene (betamethasone).
Shortages of the two Sanofi products have been felt since October, the Daiichi Sankyo product since November and the Schering-Plough product since December.
Diebolt told APM in an interview: "As chairman of the SNMR, I have to make sure patients can access care and that rheumatologists can treat them satisfactorily." Diebolt is a rheumatologist with a practice in Obernai (Bas-Rhin).
He added that the shortage represents a public health problem and expressed surprise that the minister has not even acknowledged his letter, let alone replied to it.
Contacted by APM, Fabienne Bartoli, deputy director general of the French health products safety agency (Afssaps), said that an initial stock outage of Altim in October, because of a production problem, meant the other products were oversubscribed.
Bartoli said that so far the stock shortages apply to pharmacies only; hospitals receive products on a quota basis.
A meeting with Sanofi-Aventis officials was scheduled at Afssaps on Monday evening, in the presence of executives of the French society for Rheumatology (SFR). Contacted by APM, neither Sanofi nor SFR had any comments they wished to make on Monday.
Bartoli said that if it were not possible to solve the problem immediately, Afssaps would set out a priority process for the products together with rheumatology representatives, including SFR representatives.
A spokesperson for the French arm of Schering-Plough told APM the company was doing its best to meet demand. The company is expecting supplies in January but they will probably fall short of the requirements.
The spokesperson said that the Diprostene shortages affected pharmacies only, but she warned that hospitals could be affected if too many patients go there (community rheumatologists can send their patients with a prescription for an injectable corticosteroid to a hospital pharmacy that will dispense the product to them).
NEW HEXATRIONE SUPPLIER
While it seems that the Diprostene and Hydrocortancyl shortages are a consequence of the shortage of Altim, the shortage of Hexatrione is the result of a different problem. Hexatrione is the only product, out of the four, indicated in juvenile idiopathic arthritis.
In an interview with APM, a Daiichi Sankyo France spokesperson said there has been a change in supplier.
The product used to be supplied by Axcell Biotechnologies, a company in Lyon that produces a vaccine to protect against leptospirosis that was bought by Imaxio, early in 2009. The product will now by manufactured by IDD-Tech, another company in the Rhone region.
The spokesperson said Daiichi Sankyo had prepared for the change in supplier but that the production set up took longer than expected. She said the validation process had posed problems.
According to an Afssaps regulatory affairs official, the agency received a file on the site transfer process on Dec 24, but it will take three months to process the file. Daiichi Sankyo says it can supply the product as soon as the green light is given.
Consequently, the Daiichi Sankyo spokesperson said the shortage would last until April. The shortage affects pharmacies, but not hospitals.
When asked to provide details on the product shortages, Diebolt said that as soon as he learned of the Altim shortage, he prepared two months' stock, and he issues the required product to a patient, who re-supplies the rheumatologist if a pharmacy can make good the prescription.
Diebolt said his stock was getting very low and would run out in 10 days' time. "Then I'll have to put my patients on oral corticosteroids," he said. However, oral corticosteroids have side effects, with cardiovascular consequences.
rl/aki/nh
[17739] 12/01/2010 10:42 GMT - INDUSTRY
