The Ministry of Health and the communities have imposed a special control for the new fast-release fentanyl treatments, a formula that eliminates pain instantly and that is 100 times more powerful than morphine, to stop the increase in addictions to these painkillers. The measure is included in the new Opioid Plan, although its entry into force was advanced to July 1 without it having transpired so far. The objective is to limit the use of these drugs only for cancer patients with breakthrough pain (sudden and of great intensity). Although this is the only indication included in the technical sheet, one out of every four units sold so far was prescribed for other patients, especially people suffering from chronic pain unrelated to cancer.
The new system uses the visa formula, a process in which the prescriptions prescribed by doctors are reviewed by an inspector before the patient can withdraw the medicine and it is financed by public health. This inspector is responsible for preventing these drugs from being administered to other patients, except in cases of “exceptional character”, explains a spokesman for Health. The ministry has not answered EL PAÍS’s questions about how it plans to extend these controls to private healthcare.
The plan is the result of more than two years of work that has been slowed down by the pandemic and started by the increase in cases of abuse and addictions to the most potent formulas of opiates detected in some communities. A problem in which Spain and other European countries are so influenced by fear of the huge public health crisis that occurred in the United States – where it is estimated that more than 500. people have died from the uncontrolled prescription of these drugs— as the need to alleviate the suffering and pain of dozens of thousands of patients.
“The existing controls in Spain make it impossible to repeat what happened in the United States. We must improve the administration of these drugs and the monitoring of patients, but also be aware that opioids are the only therapeutic alternative for many patients. There is more hope of life and people want and have the right to live it with dignity. This means doing it without pain, although it must be done properly to maximize the benefit and minimize the risk ”, explains Ana Mínguez, an expert who has participated in the preparation of the Plan by the Spanish Society of Hospital Pharmacy (SEFH).
Increase of 52% in seven years
The The increase in the use of so-called major opioids – which excludes the less potent formulas, such as tramadol and codeine – has been 52% in the last seven years, although experts recall that this is not a negative fact if one takes into account that, “with proper use, the suffering of many patients is avoided”. On the other hand, it is “the growing consumption of immediate release fentanyl”, which has caused “significant concern about its use outside the authorized indications”, states the Plan, in the preparation of which Health, the communities and the a score of scientific societies. The annual report of 2019 of the International Narcotics Control Board (INCB) highlights that Spain is the fourth country with the highest consumption of fentanyl in the OECD, behind the United States, Germany and the United Kingdom. United.
According to the Plan document, the consumption of major opioids has increased between 2013 and 2019 from 3, 57 to 5, 42 daily doses defined by 1. 000 inhabitants (DHD, the most used technical measure to measure the consumption of a drug in relation to to the population). The differences between communities are important and range from 3, 57 DHD in which this is lower (La Rioja and Navarra) to 7, 74 where it is highest (Galicia and Valencian Community). Fentanyl is the most widely consumed opioid, with about 60% of the total, although the rapid release presentations, by nasal and buccal route, represent a fifth part of the total consumption of this molecule.
In Spain, no data have been made public that dimension the magnitude of the problem of addictions and deaths caused by the abuse of opioids. One of the first studies that tried to do so was presented in 2019 by the Pain Observatory of the University of Cádiz and estimated that the annual deaths related to opioids had grown from 691 in the year 2010 to 1. 049 in 2017 (one more). The work, however, did not distinguish between accidental and intentional deaths, nor did it detail the type of opioid involved.
The imposition of the visa is, however, a controversial decision for several reasons. Some are related to the misgivings that many doctors have with this mechanism, perceived as a bureaucratic obstacle and a review of their clinical criteria carried out by an inspector who does not know the patient. But the underlying debate is the restriction of the use of rapid-release fentanyl in non-cancer patients.
According to the Plan, between a 11% and a 17% of the population suffers pain chronic disease not related to cancer and the most frequent causes are osteoarthritis (56%), low back pain (27%), neck pain (27%) and migraine or headache (5%). The document states that “the role” of rapid-release fentanyl should be re-evaluated in these patients “due to insufficient evidence of long-term effectiveness, potential adverse effects and the progressive increase in related addiction problems.” Consumption of this type of opioid off-label now amounts to 27% of total prescriptions, according to the document, that do not offers more specific data.
Ana Mínguez, who works in the pain unit of the General Hospital of Valencia, considers that “there are non-cancer patients who, with due follow-up, could benefit from fentanyl presentations” that are now intended to be limited, which are administered by the nasal and buccal route (there will be no changes with the presentations in patches). This specialist illustrates this with a fact: “Most of the patients we attend to in the pain unit are not cancer patients, but older people.”
Juana Sánchez, from the Spanish Society of Physicians General and Family (SEMG) and which has also participated in the development of the plan, is not very enthusiastic about the visas. “It is something that has the risk of excluding patients who can benefit from these drugs. But it is true that we have seen that the majority of addiction cases are related to the inappropriate treatment of fast-release fentanyl in non-cancer chronic pain. These presentations greatly increase the tolerance that patients who take opioids tend to develop. and they increase the risk of addiction ”, he explains.
Many times, experts point out, addiction problems arise after poor control over the evolution of the patient. “In some cases there has been poor control of patients who were prescribed rapid-release fentanyl without adequate follow-up. There are not many, but it is a problem that exists and that the Plan intends to address ”, adds Sánchez.
The visa will not be necessary for patients who have already been taking rapid-release fentanyl. For these cases, the Plan intends that, whenever possible, treatment is changed to other less problematic opioids. In more complex cases, referral of the patient “to the specific addiction circuit” is foreseen, which includes “detoxification programs”, “the use of methadone” and “the rotation of opioids”.
The care of these patients is one of the lines of action that the Plan plans to develop. Other measures seek to “optimize the prescription” with various actions aimed at healthcare professionals; improve communication with the sick and “raise awareness among the population”; “Improve the identification of patients with opioid use disorder”, and establish mechanisms that allow better surveillance of the use of these drugs.