In the absence of medication for epilepsy, the Ministry of Health proposes to reduce the dosage

In view of the lack of one of the main medications for the control of epilepsy, the Ministry of Health is proposing to distribute the same medicine with a dosage equivalent to one third of that which is lacking (from 750 mg to 250 mg).

The exchange proposal is contained in an official letter sent to the State Departments of Health and provoked indignation from patients, family members and the medical profession, who started a movement of rejection on social networks.

The drug is levetiracetam, which was included in the list of medications for epilepsy in the SUS in 2017, but was only made available in 2020 in the SUS. In the US and Europe, the drug has been available for at least 20 years.

In the official letter, the Ministry of Health acknowledges the lack of medication in the presentation of 750 mg (higher dose in pills), claims that consumption was higher than expected, says that a bidding process for the purchase of the medicine failed in September, but what else is going on.

The ministry also claims that it has a “reasonable” stock of the drug levetiracetam 250 mg, and proposes to send it to the state secretariats to “facilitate the exchange/replacement of drug therapy for patients treated with levetiracetam 750 mg, at the physician’s discretion prescriber”.

On the last 22nd, the ABE (Brazilian Association of Epilepsy) sent a notification to the Ministry of Health in which it classifies the shortage and the proposed exchange as unacceptable. “It represents a government negligence towards patients with epilepsy, putting their treatment and even their lives at risk, in addition to overloading the system with last-minute changes.”

According to neurologist Lecio Figueira Pinto, coordinator of the adult epilepsy clinic at Hospital das Clínicas, the ministry’s proposal is unreasonable for several reasons, starting with the fact that there is hardly any stock to meet the high demand for the drug. “The 250 mg dosage will quickly end and we will have another problem, waiting for the purchase of another dosage and disfavoring patients again.”

He claims that these changes in pill dosages can confuse patients, lead to errors and reduce adherence to treatment. “This has already been studied and proven in scientific works.”

In the letter, the ministry also says that there will be a need for new documentation, such as a request report, evaluation, authorization, LME (specialized medicine report) and prescription, for all patients who, on medical advice, are indicated for exchange/replacement of levetiracetam 750 mg by that of 250 mg.

“This guidance is incompatible with the resources made available for the care of people with epilepsy in the SUS. This will imply a need to look for doctors and care units, to exchange medical reports and prescriptions. It is laborious, it will consume time that does not exist in a system of health overload that we have”, explains the neurologist.

Not to mention the fact that there is a shortage of these specialists in the SUS. On ABE’s Instagram page, there are several reports from patients about the difficulties of scheduling appointments with neurologists.

Marcia Lima, from Vila Velha (ES), for example, says she has been waiting for three years for an appointment with a neurologist to change her medication and try to have more control over her epileptic seizures. “I haven’t seen a specialist doctor for more than five years.”

Figueira Pinto recalls that, to make matters worse, the exchange proposal takes place at the end of the year, when there is even greater limitation of access to health services due to holidays and recesses. “Even if the patient can get a doctor to exchange prescriptions, he will have to enter and wait days for the new dosage to be released.”

According to Maria Alice Susemihl, president of the ABE, the lack of levetiracetam 750 mg occurs nationwide. The purchase is centralized at the Ministry of Health. “They didn’t make the purchase at the right time, they only went to do it when the stock ran out. This impacted the entire country.”

In the letter sent to the health secretariats, the ministry says that there are other drug therapies for epilepsy and that, after the failure of the bidding process for the purchase of levetiracetam 750 mg, a new one is in the process of analyzing the technical documentation.

“Despite the efforts and constant search for speed, the aforementioned acquisition negotiations required the passage of a significant timeless lapse, which impacted the supply of medicine to the SUS network”, says an excerpt of the letter.

In the country, it is estimated that there are 3 million people with epilepsy. The disease can occur as a genetic disorder or as a result of acquired brain damage, such as problems with childbirth, trauma, stroke or even diseases such as neurocysticercosis (infection of the central nervous system).

For Susemihl, as absurd as the shortage is the proposal to change the dosage that the Ministry of Health made to the secretariats. “There is no way to stop a drug for a person with epilepsy in this way. I would have to wean the drug to try to enter with another one.”

She says that many patients are having seizures due to the lack of medicine. At pharmacies, the drug costs around R$300 a box. “The situation is quite serious,” he says.

On social networks, patients and family members have mobilized through the hashtag #SOSEpilepsia and gathering signatures for an online petition that denounces the lack of care for epilepsy.

Jessica Ribeiro says she has not taken the drug for three months because she can no longer find it in the SUS high-cost pharmacy in her city. Until September, she was taking two 750 mg pills a day.

A mother from Navegantes (RS) claims that she started making cucas (German candy) to help buy medicine for her son. Tainá Gomes says that he spends R$300 per month on medication, but that he ran out of money and had to stop. “I had several seizures of dissociation, but, thank God, I didn’t have seizures.”

Neurologist Figueira Pinto says that, as it is a drug with a different mechanism, without drug interactions and safe in women who want to become pregnant, levetiracetam quickly became widely used, and the Ministry of Health should know about it.

“This was easy to predict based on the characteristics of the new medication and the demand from patients for new options after all these years of neglect by the Brazilian government regarding the health of these people.”

In the notification sent to the ministry, the ABE requests that levetiracetam 750 mg be in high-cost pharmacies until January 15th. It also asks that, while there is a lack of medicine, the state departments can switch to the 250 mg version without the need for the patient to present new documentation.

wanted by leaf, the Ministry of Health did not respond to questions about the shortage and about the new proposal to change the dosage of the drug.