How the French Medecine Authority addressed the Technetium crisis information

Objectives The “technetium crisis” was managed in France by the French Health Products Safety Agency (AFSSAPS), in close cooperation with the French ministry of Health (FMH). Actually in the EU, each member state must manage the consequences of a shortage in any nationally registered medicine. This is the case of almost all 99mTc radiopharmaceuticals, just a few being registered “centrally” by EMEA, the European Medicine Agency.

Methods Information. As soon as Sept 1^st a FMH-AFFSAPS press release reported that “one reactor at Petten (NL) producing 99Mo has been shutdown during maintenance of other Eur reactors. A shortage in 99mTc generators is anticipated. Alternatives exist in radiology and nuclear medicine (NM)”.On Sept 3rd, AFSSAPS website explained the major indications of 99mTc (bone, myocardium and lung imaging), the supply of 99mTc generators and the causes of the crisis, recommending alternatives to 99mTc scintigraphies, optimal use of 99mTc and replacement by other examinations in NM or radiology.On Sept 5^th, information was mailed to all French health care workers.

Results Consertation. on September 7 AFSSAPS met the representatives of NM , all firms marketing 99mTc generators in Fr; 5 priority situations were defined, likely to represent 20% of 99mTc activity used before the crisis: - suspected pulmonary embolism in pregnant women,- contraindication to contrast media- urgent sentinel lymph node detection. - urgent preoperatory localisation of parathyroid glands - paediatric NM, when alternatives are more irradiating.

Conclusions Decision. To ensure a minimal supply to all regions of France, at least 30% of the ordered activity of 99Mo (minimum 2 GBq/week) should be delivered to all NM centres.Monitoring. Adequate supply of 99Mo generators to the NM centres has then been monitored each week.