Spanish Medicines Agency warns of shortages of popular cancer drug

AEMPS, the Spanish Medicines Agency has urged the pharmaceutical company that manufactures Hydrea to control and limit its sale.

This action has come about as the result of reported shortages of the popular drug used to treat cancer patients in Spain. The commercialisation of this drug in Spain is carried out by Laboratorios Rubió.

In recent weeks there have been several cases of this type both in Spain and internationally, but one of the most notable has undoubtedly been the ‘serious lack of supply’, of Hydrea reported by patients.

Hydrea contains the active substance hydroxyurea and is indicated for the treatment of some proliferative diseases of the bone marrow.

These include polycythemia vera (a type of blood cancer) and essential thrombocythemia. It is also prescribed for certain types of chronic myeloid leukaemia and head and neck cancers. Finding Hydrea in pharmacies in recent months seems to have become quite a challenge though.

According to the health agency, the supply problems of Hydrea – which is only available by prescription, and is impossible to replace with another treatment – have been accumulating since mid-April this year and are expected to last until July 28.

According to AEMPS, that is the date on which fresh supplies of the drug are expected to arrive in Spain, as reported by larazon.es.

The General Directorate of Humanisation, Benefits and Pharmacy of the Government of La Rioja has issued a statement informing that the medicine will be imported from a foreign country by the Aemps Medicines in Special Situations Service.

Referring to the alternative proposed by AEMPS, in a statement, the General Directorate detailed: “For its dispensation in the Pharmaceutical and Medication Ordering Service, it will be necessary for the patient to present the corresponding medical prescription, either on paper or electronically”.

Laboratorios Rubió also issued an official statement yesterday, Monday, June 12, to guarantee that measures are being taken to normalise the distribution of Hydrea ‘as soon as possible’. The company added that it hoped to be able to resolve the issue ‘in the coming weeks’.

The pharmaceutical distributor called for peace of mind for those affected and ensured that it was ‘working closely’ with its suppliers and other relevant actors to ‘overcome these challenges and fully restore Hydrea’s supply’.

Rubió explained that these incidents with the medicine manufactured by Cheplapharm Arzneimittel GmbH and that their company distributes, are the result of ‘the global shortage of aluminium, an essential component for the proper packaging of pills’.

Aluminium is used in the blister packs that contain the Hydrea tablets, argued Rubió, pointing out that it was: ‘crucial to guarantee their protection and to print the necessary product information on the package’.

‘Unfortunately, this aluminium shortage has temporarily impacted us, hindering our ability to supply Hydrea to patients in need’, the statement continued.

However, the laboratories said they were: ‘Taking steps to resolve this situation as quickly as possible. We expect to be able to receive the necessary supply of aluminium in the coming weeks, which will allow us to normalize Hydrea’s distribution without further delay’.

Finally, the distributor said that it appreciated: “The understanding of patients and their families during this period”. It assured that the company was committed to: ‘maintaining transparent communication and providing timely updates’ as they progress in resolving this situation.