Ministry of Health is alerted about low stock of injectable dipyrone in municipalities

The Ministry of Health has received alerts of low stock of injectable dipyrone in municipalities and hospitals.

The formal notices were made by Conasems (National Council of Municipal Health Departments) and by medical entities.

SUS managers told the sheet that, if there is no regulation in the market, there is “an imminent risk” of shortages of this medicine for hospital and pre-hospital use.

While at one end there is a concern with shortages, at the other end, the pharmaceutical industry is giving up on producing the medicine due to the increase in inputs.​

The possible lack of medication can have consequences for the population, given that hospital use is very high and difficult to replace in the country.

The other pharmacotherapeutic options available may have limited results, depending on the patient’s profile and the expected clinical outcome.

Mauro Junqueira, executive secretary of Conasems, said that municipal managers are having difficulty acquiring the medicine. Tenders are running out of bidders.

“It’s not a critical situation yet, just a warning. [ao Ministério da Saúde].”

In the letter sent to the folder, Conasems showed a survey carried out with five Brazilian laboratories that manufacture dipyrone. In three, there was a stop in production. Another two were in high demand.

Only one injectable dipyrone manufacturer reported the temporary suspension of production to Anvisa (National Health Surveillance Agency) due to the high cost and low added value for sale.

“We come to you to request urgent actions from this Ministry of Health to intensify market regulation and a strong articulation with the pharmaceutical sector so that we can have guaranteed access and the regular and sustained supply of these treatments”, said Conasems, in the letter .

Nelson Mussolini, executive president of Sindusfarma (a union that brings together the pharmaceutical industry), said that the production of injectable dipyrone is unfeasible for the industry due to the high inputs, which are 100% imported. Thus, the final price of production is getting more expensive than the marketed price.

“There was a great demand for the drug in the pandemic and the price of inputs increased a lot, in addition to the freight and the vial. We even thought that the freight would decrease with the control of the pandemic, but it did not happen”, he highlighted.

In Brazil, prices are regulated by the CMED (Chamber of Regulation of the Medicines Market), which sets the limit at which a medicine can be marketed.

Anvisa said, through a note, that there is a request for a price adjustment for dipyrone. It is being analyzed by the federal government ministries that make up the CMED.

The Ministry of Health was contacted, but did not respond to questions about what it would do to regulate the market. He only said that the federal transfer is regular, and it is up to the states and municipalities to purchase and make the medicines available to the population.

Mussolini pointed out that there is no problem in the production of dipyrone in other formats, such as the pill sold in pharmacies. This is because the industry has control over the price of that product.

Anvisa said that the regulation of drug prices in Brazil does not apply to some categories, such as the so-called MIPs (over-the-counter drugs).

These include, for example, anti-flu, muscle relaxants, analgesics, among others. On the other hand, prescription and hospital use drugs have their prices regulated. This includes injectable dipyrone, which has different dosages and indications.

Anvisa added that essential medicines, registered in Brazil and meeting the requirements of quality, efficacy and safety, are no longer being marketed in the country, resulting in shortages and jeopardizing the maintenance of treatments and patient safety.

“Many times, companies claim economic disinterest due to the pricing policy practiced in Brazil. Thus, we point out that it is urgent to discuss the improvement of the current regulatory model, seeking to promote a balance between profits and affordable prices for society”, said in note.​

In addition to the letter sent by Conasems, the other document was signed by the entities Amib (Association of Brazilian Intensive Medicine), ISMB (Institute for Safe Practices in the Use of Medicines), Rebraensp (Brazilian Network of Nursing and Patient Safety), SBA (Society Brazilian Society of Anesthesiology), Sbrafg (Brazilian Society of Hospital Pharmacy and Health Services) and Sobrasp (Brazilian Society for the Quality of Care and Patient Safety).

The entities also forwarded the document to Anvisa, Conasems and Conass (National Council of Health Secretaries). In the letter, representatives of the associations point out that access to this and other medicines is a condition for the effectiveness and safety of the treatment, and shortages can represent a serious risk to life.

“We understand that all administrative efforts are necessary at this time and we hope that the information can support a quick assessment and the discussion of immediate contingency strategies for this problem. We reaffirm that we are available to contribute to better serve all citizens and patients,” he said in a statement.