The AEMPS has reached an agreement with the main companies on a series of recommendations to optimize the use of available units
The Spanish Agency for Medicines and Health Products (AEMPS) has issued an alert for shortage of fibrinolytic drugs that is, those used to prevent thrombus problems, due to the increase in demand, mainly for Metalyse and Actilyse, marketed by Boehringer Ingelheim España, SA
Because its production capacity is limited, the company is carrying out a controlled distribution of the available units of these medicines until it can increase its manufacture and is prioritizing the production of Actilyse to cover a greater number of needs, the AEMPS has reported.
Meanwhile, the agency, together with the companies involved in the use of this type of medication, has drawn up a series of recommendations to optimize the use of available units. Together with the Spanish Society of Neurology (SEN), the Spanish Society of Intensive and Critical Medicine and Coronary Units (SEMICYUC) and the Spanish Society of Nephrology (SEN), the AEMPS has agreed:
The use of alteplase should be limited to its authorized indications: ischemic stroke, myocardial infarction, and high-risk pulmonary thromboembolism (PTE).
The use of tenecteplase should be limited to its authorized indication: myocardial infarction.
The use of urokinase should be considered as an alternative to alteplase for high-risk PTE and also for unblocking catheters (in preference to other fibrinolytics).
Alteplase or tenecteplase should not be used off-label. In particular, its off-label use for catheter unblocking is not recommended.
It is possible to have reteplase, a drug not marketed in Spain, as a bolus alternative to tenecteplase (eg in mobile ICUs). To do this, it is necessary to assess the specific needs and contact the AEMPS Medicines in Special Situations Service (MSE), which will be in charge of reporting on the availability of the medicine and the conditions of acquisition.
In any case, from the agency they remind that they keep the list of medicines with shortage problems active so that they can be consulted at any time.
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