On Tuesday, the French National Agency for Medication Safety (ANSM) presented a new regulatory framework for prescriptions for 3rd and 4th generation contraception pills. From June 2013, "doctors must indicate in writing on the prescription that they have verified the absence of counter-indications and informed the patient about the risks of thrombosis." The adoption of this new procedure "should drastically limit the consumption of oestrogenic and progestogenic pills of the 3rd and 4th generations, deemed to be excessive in France." Dominique Maraninchi, Director General of the ANSM, points out that the application of these new rules due to start in June is owing to the fact that the packaging of these medications will have to be modified "with the insertion in the boxes of a special information card for patients reminding them of the signs of thromboembolic events that must alert them." Moreover, the journalist adds that "this decision on health involves […] changing the AMM [Authorisation to Market] for these contraceptives since they are henceforth reserved as a second option."
3rd and 4th generation contraception pills: the ANSM lays down new prescription rules
Publié le : 5 March 2013