Health restricts the use of cancer treatment due to supply problems

The Spanish Agency for Medicines and Health Products (AEMPS), dependent on the Ministry of Health, has recommended that professionals in the health system make controlled use of the available units of cisplatin, an active ingredient used against several types of cancer, due to to the supply problems that exist with the drug.

Specifically, in a note published last Monday, the Agency requests that the existing doses be only used in “cases in which delaying treatment could compromise the probability of cure or overall survival” of the patient and in those in which “the alternatives [available pharmacological] are not adequate.”

Supply problems have not affected patients who need the drug. However, while the situation has not normalized, the AEMPS has activated measures such as the purchase of this medicine abroad and has activated the solidarity mechanism between European countries, a new system created last year to mitigate the recurring problems of shortage of supplies. some medications. The available doses are distributed through the Medication Service in Special Situations.

Cisplatin is an active ingredient indicated in metastatic or advanced lung cancer and in testicular, bladder, ovarian, and head and neck squamous cell cancer, also metastatic or advanced. The Agency has made these decisions together with the Spanish Society of Medical Oncology (SEOM), the Spanish Society of Hematology and Hemotherapy (SEHH), the Spanish Society of Pediatric Hematology and Oncology

(SEHOP), the Spanish Society of Radiation Oncology (SEOR) and the Spanish Society of Hospital Pharmacy (SEFH).

The incidents with the supply of cisplatin began in February, when Pfizer notified the AEMPS that the drug Cisplatino Pharmacia 1 mg/ml concentrate for solution for infusion suffered a quality problem at its global manufacturing plant. This problem, now resolved, has meant a delay in the release of batches for distribution.

Another manufacturer, Accord Healthcare, also reported during March that it would suffer supply problems for the same drug due to capacity restrictions at its manufacturing plant. This caused an increase in demand for a third identical drug marketed in Spain, Cisplatin Hikma, which the manufacturer “has not been able to cope with.”

The problem will be solved in the coming weeks, according to the manufacturers themselves, which is why in the coming weeks the AEMPS recommendations must be followed so that no patient who needs it is left without the treatment. Pfizer has informed the AEMPS that it will receive new units starting in May and June, Accord Healthcare in June and Hikma Farmacéutica at the end of May. The Agency has formally requested the three companies to bring these dates forward if possible.

These types of drug supply problems have become frequent in recent years in European health systems, which is why the European Commission is preparing a new Pharmaceutical Strategy to increase the drug production capacity and the autonomy of the continent.