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An organization administers this medicine for free in Colombia although it does not have an Invima sanitary registry. Their spokespersons assure that they will continue to do so until underlying problems are resolved in populations with addiction.
In early November, Invima published a health alert on its website about a drug called naloxone. It was a three-page document in which he warned that a batch of that product was being fraudulently marketed in Colombia and asked that no one consume it. He asked the health secretariats to carry out all inspection and surveillance activities. “Take the necessary measures and manage their destruction,” he ordered.
Julio César Aldana, director of that institute, had also drawn attention on his Twitter account: “We warned about the fraudulent marketing of batch 13318EV of the product naloxone hydrochloride 0.4 mg / mL, which does not have a sanitary registration,” he said in a trill. Later he wrote in another: “As it is not covered by a health registry, the safety and efficacy of the product have not been proven; therefore, it is a fraudulent product that does not guarantee compliance with quality criteria ”.
Those who are part of the Acción Técnica Social (ATS) corporation, which works to promote and defend the human rights of consumers of psychoactive substances, did not like this news at all, since the lot that Invima had denounced belonged to them. to them.
Then, they summarized the discomfort caused by the health alert in a press release whose title synthesized their main dislike: “Naloxone saves lives and the Government is determined to prevent it. In four pages they explained that this drug is an antidote to overdoses caused by the consumption of opioids (heroin, for example). That someone can have it on hand, they argued, means that a family member or friend can save the life of someone with an overdose. It is enough to have a basic knowledge to be able to inject it.
ATS was right. In the wake of the opioid crisis in the United States in the past decade, naloxone became more popular. In 2015, more than 33,000 people died from opioid overdoses in that country; in 2017, more than 70,000. Naloxone, then, was one of the solutions to avoid deaths.
“All people who overdose on opioids, whether with a prescription drug or an illicit drug, need naloxone (…) Because overdoses can happen anywhere, it is designed for anyone to use. even a bystander, ”noted the US FDA in 2019.
“We want everyone who may witness an opioid overdose – family, friends, or neighbors – to have access to naloxone and feel safe using it during an emergency. Without naloxone, the risk of an overdose being fatal is significant, “said Douglas C. Throckmorton, a spokesman for the FDA, while highlighting the efforts of several states to allow patients to purchase that drug without a prescription. “That has made a difference in many communities,” he added.
The reason for its importance is that naloxone completely reverses the effects of an opioid overdose. Also, it does not cause serious secondary problems. The World Health Organization also recommends that this drug be available to people who may witness an overdose. Providing it “in combination with training on the use of naloxone and resuscitation of people after an opioid overdose could substantially reduce the number of deaths resulting from an opioid overdose,” he says.
This is precisely one of the concerns of ATS: that in Colombia, they explain, naloxone is not reaching the streets or those who should have it on hand. “That is why we are delivering it. And as long as the Government does not do it, we will continue to do so. The last distribution we did was on August 30th. We gave 1,800 light bulbs in 18 points in eleven cities. We are saving lives ”.
The problem is that the naloxone that ATS is delivering does not have the permission that every medicine must have to be distributed in Colombia: the Invima sanitary registry.
A bigger problem
Diana Calderón is Invima’s Director of Medicines and Biological Products and she also has good reasons to explain why they published the health alert of November 3: “The health registry is the way to guarantee that a product is safe and effective for patients. If you don’t follow that process, we have to do our duty. In addition, it is not true that there is a shortage. There are three companies that have a sanitary registration to import and market it. Minsalud projections indicate that some 2,700 units are required per month. According to the holders of the records, there are 62,000 units ”.
“Medicines cannot enter Colombia without the authorization of Invima, which is the one that has the capacity to guarantee their quality,” adds Leonardo Arregocés, director of the Office of Medicines and Health Technologies of the Ministry of Health. “We cannot allow them to enter without the sanitary registration. How about a patient using a vial that is not safe? What are the consequences? Who takes responsibility ”.
Why, if one of the problems is the sanitary registry, ATS does not manage it? The organization claims that it is a very expensive and lengthy process for which they have no resources and would slow down the delivery process to consumer users who need the naloxone. “We distribute it under the criteria of humanitarian emergency care. They are donations that US NGOs make to us and we distribute them free of charge. It is possible that the pharmaceutical companies that sell them in Colombia do not like that ”, they say. “In most public and private harm reduction programs and those of civil society organizations in Colombia, the only naloxone available is the one described in the Invima alert. We are faced with a new case of government action in which they do not do and do not allow them to do it, ”they insist.
Arregocés does not agree very much with the position of ATS. In addition to criticism for the lack of health registration, he does not believe that the Ministry of Health is imposing access barriers to those who need naloxone. “Naloxone, as the guide we published in 2017 says, should be in people’s pockets. That is undeniable. It can save lives and must be accessible. In fact, it is mandatory that all hospitals and ambulances have naloxone, ”he says.
However, he admits that one of the difficulties is reaching the community level, where ATS moves more easily. And one of the obstacles is that, unlike countries like Australia, Canada, Italy or the United Kingdom, which allow the free sale of this drug, in Colombia you need a prescription. “We have to work on that. I believe that it is necessary to do everything possible so that in the country it is free sale. The figures from the Observatory of Drugs of the Ministry of Justice show, indeed, that 67% to 77% of overdoses were witnessed by someone and that someone was able to give treatment. But it is false that it is not available. While 112,000 ampoules were sold in 2010, in 2019 they were 780,000. In fact it is in the Benefits Plan. If a doctor prescribes it, a user has the right to receive it ”.
“But how long do you have to wait to get an appointment with a specialist to formulate it?” They ask at ATS. “About three or four months. Meanwhile there are patients who need them ”. In the organization they insist that they will maintain their position: “We are going to continue delivering the vials, because the Government, as it says in the 2017 guidelines for the management of opioid overdoses of the Ministry of Health, must take it to the community and it is not doing so. We cannot wait ”.
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