More medicines in Spain face supply problems as another drug is added to the list

More medicines in Spain face supply problems as another drug is added to the list

A widely-used drug used in chemotherapy treatment for multiple types of cancer can now only be administered to patients considered a 'priority'

Álvaro Soto


Tuesday, 23 April 2024, 13:09


Oncology units in Spanish hospitals will face the next two months without one of their most widely-used drugs, Cisplatin.

The Spanish Agency for Medicines and Health Products (Aemps) has restricted the use of the drug, a chemotherapy treatment used for multiple types of cancer, which from now until the end of June should only be administered to patients considered a 'priority'.

Aemps, which reports to the national ministry of health, has asked doctors to increase the intervals at which the drug is administered and to optimise all vials, "avoiding discarding excess medication".

The alarm raised last week over the Cisplatin shortage is the latest in a series of common drug supply issues. In Spain, some 4% of drugs suffered some kind of supply problem, but only 0.17% caused an "impact", such as having to be replaced by another compound or, in the most serious cases, forcing Aemps to take extraordinary measures.

According to a report on supply problems, which incorporates data from the second half of 2023, supply problems are defined as "a situation in which the available units of a medicine in the pharmaceutical channel are lower than the national consumption needs".

Spanish pharmacies are home to 32,992 drug presentations, corresponding to 15,503 authorised medicines. Of these, 4% (1,415) experienced a supply problem in the second half of last year and 115 are the ones that caused most disruption to patients, as they required adaptation or intervention by the Aemps - which has now happened with cisplatin. On the positive side, the number of medicines for which supply problems were reported between July and December last year fell by 7% compared to the first half of 2024.

In 2023 as a whole, the health body tried to avoid shortages in different ways: by carrying out a controlled distribution of the available units; by seeking alternative medicines, through meetings with laboratories to check stocks; by authorising exceptional marketing (medicines identical to Spanish medicines, but with the label of other countries, in 438 cases); by limiting exports (on 209 occasions) or increasing imports (which occurred with 77 medicines). Spain can appeal, as it has done with cisplatin, for European aid.

Global problem

Coordinator of Gedefo (oncology pharmacy group) of the SEFH, Garbiñe Lizeaga, said the lack of certain drugs is a "global" problem that can be explained by "production difficulties in factories and by peaks in demand", as sometimes drugs are produced in only a few factories, but consumed "all over the world". The main causes of supply chain breaks were manufacturing plant capacity problems (36.4% of cases); increased demand (23.6%) and manufacturing issues not due to lack of quality (18.6%).

In its half-yearly report, Aemps pointed out three medicines for which it was forced to take exceptional measures last year. For Inyesprin, which is used for rheumatic, neuralgic and post-traumatic pain, the exceptional marketing of units with a shelf life of less than six months was authorised, and for Fluradabine, used in the treatment of chronic lymphocytic leukaemia, and Sotapor, a tablet for arrhythmias and tachyarrhythmias, the foreign import of the medication was carefully managed.

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