2023-11-16 01:02:02
Scientific medical societies, academics and non-governmental organizations urged the authorities to initiate an investigation into the drug Methotrexate (or Methotrexate), used to treat leukemias, which generated adverse reactions in patients in the Hematology service of the JM de los Ríos children’s hospital.
In a press conference this November 15, representatives of the societies and organizations released a statement which urges the Attorney General of the Republic, Tarek William Saab; the ombudsman, Alfredo Ruiz, and the president of the 2020 National Assembly, Jorge Rodríguez, to exhaustively investigate the facts and request the pertinent administrative actions.
According to the organizations’ registry, at least 22 patients of the service, who received Methotrexate between August and September (first 10 in August and then 12 in September), had adverse effects with symptoms such as fever, vomiting and pain. Some presented meningitis, one patient died and in another patient a bacteria was detected, effects that are not expected following the application of the medication.
“All the children received antibiotics and improved. The only one who did not receive antibiotics because he had a problem with a poor venous network and who might not even be given a central line because he had severe problems, that patient died,” said hematologist Maribel Meléndez, president of the Venezuelan Society of Hematology (SVH). ).
The statement, read by Dr. Huniades Urbina-Medina, vice president of the National Academy of Medicine, highlights that a microbiological analysis of a bottle of Methotrexate, carried out in a private laboratory, confirmed the presence of the bacteria. Klebsiella pneumoniae y Pseudomonas aeruginosa.
Due to the characteristics of the case, the spokespersons point out that it is likely that the medication was contaminated “at the factory.”
Without evidence from the authorities
The lot referred to is OI21111with manufacturing date 10/2021 and expiration date 09/2023 (Code N: HP/ Drugs/ BNZ/20191145), manufactured by NaxparPharm Laboratory, Pvt. Ltd. Mumbai, in India, imported and distributed by the Institute Venezuelan Social Security Institute (IVSS).
Given the results of the first analyses, the doctors from the Hematology service refused to continue administering the medication until the authorities confirmed that the batch was safe and had passed the quality and safety controls.
According to the statement, representatives of the Ministry of Health and the IVSS expressed in a meeting with the doctors that “all the medications had passed the quality controls,” but they did not show evidence or documents or anything to support that statement. They also did not bring documents regarding the new batch of Methotrexate that had been sent to the hospital.
The results never came and the doctors were verbally threatened by the hospital board of being reported to the Prosecutor’s Office, “for violating the patients’ right to receive the treatment that corresponds to them,” a situation that led to the resignation of the center’s five specialists.
The Venezuelan Society of Childcare and Pediatrics also participated | Photo: Cocuyo Effect
Gladys Velásquez, president of the National Center for Bioethics (Cenabi), highlighted the bioethical implications of administering medications whose safety is not verified.
“We must highlight the bravery of the doctors who refused to administer something that might make these children sick, that might cause their death, since they did not have any certification or written evidence that the medicine had been analyzed by the Institute of Hygiene,” express. “Those who have to give the answer to what quality that medicine has are the authorities.”
From the Ministry of Health, they promised families to keep the service operational at JM de los Ríos. The five specialists were replaced by two doctors who, although they are hematologists, They do not have specialization in pediatrics.
Currently, the service is using Methotrexate purchased by families in private pharmacies and a different batch, but from the same manufacturer as the batch in question, supplied by the IVSS.
Safety for children
For this November 15, two months following the resignation of the doctors, the organizations reiterated that the authorities have not yet presented the results of the analyzes carried out by the “Rafael Rangel” National Institute of Hygiene on Methotrexate.
“First of all, we want that a response be given from the Inhrr, We really need the clarity of knowing what happened with the research they did on the drug. We need to know if this batch was really removed from supply, if it is still being supplied domestically or what is happening,” said Katherine Martínez, director of the NGO Prepara Familia.
For the organizations, clarifying what happened in the hospital will allow them to protect the health of the children and adolescents of JM de los Ríos and the entire country. According to the societies, adverse reactions to the drug have also been reported in other states.
“Simultaneously with what is happening at JM de los Ríos, at the Venezuelan Society of Hematology, through internal communication channels, we receive complaints from other hospitals: from Mérida, Valencia and Apure. We cannot say that it is the entire batch, but some vials from that batch were apparently contaminated,” added Maribel Meléndez, president of the SVH.
“It’s not just the JM children, but we are talking regarding the children of the entire country. We have to know what has happened. “They are children who suffer a lot,” said Martínez, who also recalled that the patients of the Hematology service at JM de los Ríos are protected by precautionary measures from the Inter-American Commission on Human Rights (IACHR), but these measures are not met.
The organizations will send the communication to the Office of the High Commissioner for Human Rights of the United Nations to record and investigate violations of the right to health and life of patients exposed to the administration of the aforementioned Methotrexate.
Part of the statement shared this November 15
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