Leukemia medicine remains out of stock since 2nd trimester

​A medicine used against leukemia, dasatinib is still lacking in some Brazilian states, which say they are waiting for the transfer from the Ministry of Health. sheet, the drug has had supply problems since the second quarter of this year.

The drug is used to treat chronic myeloid leukemia, a disease that causes the increase of white blood cells in the blood, says Angelo Maiolino, hematologist and coordinator of the Committee on Access to Medicines at the ABHH (Brazilian Association of Hematology, Hemotherapy and Cell Therapy).

The public distribution of the drug is centralized by the Ministry of Health, which imports it and passes it on to the health departments of the states. After that, it is up to them to deliver it to regional hospitals, so that registered users can undergo oral chemotherapy.

The shortage of dasatinib in the 20 mg version has been registered since the second quarter of this year, according to a technical note from the Ministry of Health on 8 September. The scenario worsened in the third trimester, when there was no distribution in the 20 mg version and the 100 mg version was pending.

On August 23, the portfolio signed an acquisition agreement with drugmaker Bristol Myers Squibb. The company informed that the import of the medicine, a process that involves a request from the ministry to Anvisa (National Health Surveillance Agency), was only authorized on October 1st.

This delay meant that the drug only reached the ministry’s warehouse on October 19th. The forecast for the start of deliveries, according to the folder, would be on the 22nd of that month. However, some states report that so far they have not received the drug.

The Health Department of Mato Grosso do Sul said it “awaits information from the Ministry of Health”, and a patient who uses dasatinib who withdraws the drug at the state’s regional hospital said that there is no information on when the drug will be available.

The situation is repeated in São Paulo. According to the state secretariat, the ministry had informed that dasatinib would be delivered in the first week of this month, but so far, this has not happened.

Conass (National Council of Health Secretaries) said that “we still face a situation of shortage of dasatinib in some states”.

Wanted to comment on delays, the Ministry of Health did not respond until the report was published.

There are other drugs that can be used to treat leukemia, such as nilotinib and imatinib. However, changing medication may not be a good alternative, because the medications are not identical, says doctor Angelo Maiolino.

The hematologist said that the replacement could result in a loss of response to oral chemotherapy treatment, which could cause the transition from the chronic phase of the disease to the acute one, which is much more serious, incurable and can lead to death in a short time.

Currently, Abrale (Brazilian Association of Lymphoma and Leukemia) counts 42 complaints made by patients from different parts of the country who use dasatinib and do not have access to the drug.

The situation makes it necessary to normalize the delivery of the medicine as soon as possible, so as not to bring more problems to patients, says Maiolino.

“As the purchase and distribution is direct by the Ministry of Health, this could be a problem that will affect the entire country if it is not remedied as soon as possible”, says the doctor.

Understand why dasatinibe is used for leukemia

What is dasatinib?

The drug is a tyrosine kinase inhibitor (TIQ), a protein that comes from a genetic alteration in a stem cell that causes chronic myeloid leukemia. In addition to dasatinib, there are other inhibitors used to control the protein, such as imatinib and nilotinib.

What is chronic myeloid leukemia?

It is a disease manifested when tyrosine kinase causes an exaggerated production of white blood cells that circulate in the blood.

What problems does chronic myeloid leukemia bring to the patient?

Some symptoms are fatigue, sporadic bleeding, and an enlarged spleen and liver. In the most advanced stage of the disease, the person can die.

How does dasatinib work?

Like other ITQs, dasatinib inhibits tyrosine kinase, thereby regulating the production of white blood cells. This makes the patient remain in the chronic phase, in which there are no very severe symptoms, without progressing to critical scenarios.

What happens if treatment is stopped?

Leukemia can progress from the chronic stage to the acute stage. In the last phase, there are symptoms such as anemia, infections, bleeding and, ultimately, death.

Is changing inhibitors recommended?

Changing the drug can decrease the effectiveness of the treatment, resulting in more serious scenarios. Switching between inhibitors is only recommended when the patient is reacting poorly to treatment.