Long - term national surveillance of coagulation factors supply in France - Congrès international sur l'Hémophilie- Bangkok

Afssaps

Description

Blood and blood products
10/10/2004

Informations

• Publié par: ansm-blood-and-blood-products
• Publié le: 10 octobre 2004
• Nombre de lectures: 33
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, pas de modification
• Langue: English

Extrait

Abstract Following the shortage of FVIII in France (2000-2001), Health Authorities (DGS, DHOS, AFSSaPS) set a national control system by means of a circular (June 28, 2001), leading to a national Steering Committee (SC), including Health Authorities, Physicians (Regional Haemophilia Care Centres -CRTH-, Medical Co-ordination for Study and Treatment of Primary Haemorrhagic Disorders -COMETH-), Pharmacists (representatives of the "centralist pharmacy", the Pharmacists Order, the Hospital Pharmacists Syndicate) and the French Haemophiliac

Introduction

Following FDA inspection in Bayer production site in November 2000, the release of their recombinant factors VIII (octocog alpha) drastically felt down and could not be compensated by the other FVIII preparations available on the French market. A first meeting in March 2001 with prescribers and pharmacists, health authorities (Afssaps), patients association (AFH) and the companies (Bayer, Baxter, Centeon, LFB and Wyeth-Lederlé), lead to therapeutic recommendations which have been sent to the haemophiliac specialists. Following this first initiative, and because this need had been discussed long ahead between AFH and the French Safety Health Agency (Afssaps), Afssaps, in collaboration with the General Direction of Health (DGS) and the Hospital and Care Organisation Direction (DHOS) set a national control system by means of a circular (June 28, 2001), leading to a national Steering Committee (SC), including Health Authorities, Physicians (Regional Haemophilia Care Centres -CRTH-, Medical Co-ordination for Study and Treatment of Primary Haemorrhagic Disorders -COMETH-), Pharmacists (representatives of the "centralist pharmacy", the Pharmacists Order, the Hospital Pharmacists Syndicate) and the French Haemophiliac Association (AFH).

Results Data collected from the CRTH Pharmacies

Long-term National Surveillance of Coagulation Factors Supply in France A co-ordination between Pharmacists, Physicians, Patients Association, Health Authorities and pharmaceutical Companies.

Christelle Ratignier, Valérie Chamouard, Claude Guérois, Chantal Rotschild, Frank Huet, Edith Fressinaud, Hervé Chambost, Claud e Négrier, Edmond-Luc Henry, Marie Auzanneau, Bernadette Worms, Olivier Ballu, Christine Rieu, Pascal Paubel, Claude Vigneron, Jean-Marc Chéron, Philippe A rnaud.

Association (AFH). The SC mission was to collect data (monthly consumption and supply) from all hospital pharmacies and companies, £to adjust therapeutic recommendations according to the availability £(e.g. shortening the period of FVIII delivery to the patients down from one year to one month), and to define the threatening product availability threshold in order to adjust prescriptions. Following the end of the FVIII shortage period, this first circular has been superseded by a new one in May 28, 2003, which maintains on a long- term the Steering Committee and modifies its missions : the national Seven products are on the French market, 3 plasma-derived (Factane®, Hemofil M® and Monoclate®) and 4 recombinant products (Helixate®/HelixateNexgen®, Kogenate®/Kogenate®Bayer®, Recombinate® and Refacto®). Coagulation factors are used either in demand, that is in case of haemorrhagic event or in prophylaxis, at regular interval each week, outside bleeding time. During the shortage period in France, the regulatory system, which has been put in place by the Steering Committee, has been able to regulate the amounts of FVIII utilised, by acting mainly on the larger usage, that is surgery, immune tolerance and also by adjusting prophylaxis At the beginning, in order to collect the amounts of coagulation factors, which are only available in hospital pharmacies, utilised or delivered in the hospital and in stock in each pharmacy, a tree of collection was proposed, each CRTH pharmacy gathering information from all the hospital pharmacies delivering factor VIII in its region. In France, there are 25 regional haemophilia centres (CRTH), each under the responsibility of a co-ordinator. Four main pharmacies, one in each the 4 quarters of France were collecting data from the relevant CRTHs. In parallel, Afssaps collected all the data from the companies regarding stock and delivery of plasmatic and recombinant FVIII products marketed

Table 1 : Stock of FVIII and FIX in CRTH pharmacies during the year 2003 (UI) Coag. factors January February April March June May August July December September October November FVIII Plasm 2 170 250 2 384 500 2 021 500 2 240 000 922 000 1 732 000 1 256 000 2 314 500 882 500 2 138 000 1 178 750 22 163 750 2 Rec 6 752 250 6 346 500 8 538 250 7 044 750 6 870 000 175 5007 778 750 7 695 750 8 834 000 7 658 750 8 495 000 8 923 500 7 Total 9 942 500 9 874 500 10 633 000 10 806 000 10 074 000 9 680 250 10 922 750 10 215 000 10 066 750 8 602 500 8 602 000 8 097 500 FIX Plasm 1 351 000 1 398 750 1 170 500 1 306 500 1 527 750 1 278 000 1 472 750 1 498 750 107 0001 297 500 1 585 250 1 399 500 1 Rec 051 000 991 016 000 1 159 000 1 000 11 014 500 1 005 000 1 000 1 314 500 1 341 500 992 271 000 1 368 500 1 278 000 Total 2 312 000 2 601 250 2 450 500 2 269 000

Table 2 : Consommation of FVIII and FIX in CRTH

Coag. factors  April MarchJanuary February FVIII Plasm 545 250 2 694 000 12 147 000 2 154 750 Rec 8 166 000 9 913 750 9 088 0008 843 000 Total 10 990 000 10 782 000 12 459 000 10 320 750 FIX Plasm738 500 657 250 250 775 750 714 Rec1 396 000 586 500 1 000 861 157 000 1 Total 2 134 500 2 243 750 1 636 250 1 871 750

The first phase of FVIII data collection, during the shor France (July 2001 to June 2002), revealed that the cons CRTH pharmacies represent about 40% of the consum region, due to the fact that there are many retrocessions FIX in hospital pharmacies, which are close to the patie For the year 2003, the total consumption of FVIII in CR pharmacies was about 86 millions of UI, with 79% of r FVIII and 21% of plasmatic product, which confirms t observed in 2002. By extrapolation (40% of total consu can suppose that the national consumption of FVIII in 2003 would be about 200 millions of UI. Likewise for the FIX data, the total consumption in CR pharmacies was about 15 millions of UI, with 56% for FIX and 44% for plasmatic product. By extrapolation ( consumption), we can suppose that the national consu in France for 2003 would be about 39 millions of UI.

25

20

15

10

5

0

Recombin

2

1

1

Mean 2002 Mean 2003

eatment of only 14 days, ible, elective surgeries, ible, the start of immune tolerance, especially if s high and wait until below 10 or 5 BU,

by the 25 French haemophilia care centres gulant and anti-coagulant fractions, allows e of the stock and consumption of these factors ies, which represent about 40% of the total VIII and FIX products.

ated by the DHOS to the Lyon CRTH pharmacy n work. Distribution of the circular has been rganisation, meetings and communication ps.

tation pliant to send information every month to

collection system of monthly consumption/supply data has been extended to the whole coagulation factors, and restricted to the 25 Haemophilia Care Centres pharmacies in France. Regarding therapeutic recommendations, the period of FVIII delivery to the patients has been increased from one to six months.

Finally, we show here that the national Steering Committee is able to maintain a long-term national surveillance, in order to anticipate any shortage in coagulation factors and to improve its management.

in France. Then, these data were compiled and monthly presented to the Steering Committee. Later on, from June 2002, after the end of the FVIII shortage period, the first circular has been superseded by a new one (published in May 28, 2003), which maintains on a long-term the Steering Committee and modifies its missions. The national collection system of the monthly consumption/supply data of FVIII in each pharmacy performed by the CRTH pharmacies, and thereafter centralised by the four main pharmacies (Lyon, Marseille, Paris and Tours), has been restricted to the 25 Haemophilia Care Centres pharmacies. On the other hand, the data collecting, performed by these 25 CRTH pharmacies, has been extended to the whole coagulant and anti-coagulant fractions (FVIII, FIX, von Willebrand factor, fibrinogen, FVIIa, PPSB, FVII, FXI, FXIII, coagulation inhibitors), available on the French market in order to have markers of a potential shortage situation in any of the coagulation factors and to improve its management. All the pharmacies data are centralised and analysed by the the Lyon CRTH. Therapeutic recommendations, regarding notably FVIII delivery to patients, have been also updated in relation to the end of the shortage period (see recommendations evolution). For the data obtained from the companies, the second circular maintains the collection, performed by Afssaps, of the stock and delivery of plasmatic and recombinant FVIII products marketed in France.

• if immune tolerance should absolutely be started: to make sure that the Company is able to provide on a regular basis sufficient amounts of the FVIII to be used, • in case of anti-FVIII auto-antibody : if the treatment implies the use of human FVIII, to privilege currently more available plasma- derived products, • whenever possible, to treat adults with plasma-derived products, with good immunological tolerance. p as many patients as possible under their gimen.

2 : plies in KogenateBayer /HelixateNexgen, acities from the other companies : is not anymore necessary, patients can stay ct, en for young children can return to previous lities, ective surgeries and initiation of immune e assessed, case by case by the Steering se their possibility depends upon the product tities.

: n is still fragile, it does not seem reasonable ndations regarding prescription and delivery, hey are the only efficient regulating tool in time

t is not anymore necessary, patients can stay ct, en for young children can return to previous lities, rgeries can been programmed again, ing into account : ers, e given product, ostponed surgery. should be made by collegial decision between ating physician and the CRTH MD/PharmD. initiation requests should be assessed, case by g Committee, because their possibility depends upon the product and foresaw quantities. On May 28th, 2003 : To afford better availability and flexibility and to take into account the end of the shortage period, the validity of the validity of the initial prescription has been extended from 1 to 6 months.

Afssaps and open to present general figures to the whole committee, in the presence of each other. With this knowledge, the Steering Committee was able to adjust therapeutic recommendations, as the situation evolved. Data collection • All the 25 CRT pharmacies have been able to provide data regarding stock and consumption of coagulant and anti-coagulant fractions from June 2002 up to now. • Comparison between "pharmacies" data and "companies" data does not show any discrepancy, regarding FVIII data. • The total amounts of FVIII used each month vary from 11 (Jan 03) to 12 millions IU (Dec 03 ).

ériot LYON),Claude Guérois(CRTH Hôpital Trousseau F-37044 TOURS Cedex,Chantal Rothschild(for the COMETH, PARIS),Frank Huet(Pharmacie Centrale des ost(for the COMETH MARSEILLE),Claude Négrier(CRTH Hôpital Edouard Hériot -69003 LYON),Edmond-Luc Henry(Association Française des Hémophiles, PARIS), ion Politique de Santé, PARIS),Olivier Ballu(Direction Générale de la Santé, 3 e Sous-Direction Politique de Santé, PARIS),Claude Vigneron(Ordre des Pharmaciens, d(for the SNPHPU, Département de Pharmacie Hôpital Charles Nicole F-76031 ROUEN cedex).