VALENCIA, Spain — After watching the opioid epidemic hit the United States, spill into Canada and now Australia, all eyes are on Europe: Could the Continent be next?
Europe certainly has an issue with opioids — the No. 1 drug-related killer on the Continent. They were involved in more than 80 percent of the 8,200 drug-related deaths recorded in 2017. But the situation is playing out differently than the one in the U.S., which recorded around 70,000 opioid-related deaths in 2017, and where the epidemic has claimed almost 400,000 lives in the past two decades.
Bart Morlion, president of the European Pain Federation (EFIC), says the far tighter regulation of opioid prescriptions in Europe plays a big role, including in the stricter controls over how drug companies advertise to patients and doctors. And in many European countries, especially in the south, people are more wary of painkillers.
Europes environment “is completely different from the U.S.,” Morlion told POLITICO.
“We are prepared if the tsunami comes to Europe in the next years” — SED President Juan Antonio Micó
Spain is a good case in point. The country saw opioid consumption increase by nearly 84 percent between 2008 and 2015. But people arent flocking to emergency rooms or dying from overdoses due to their opioid prescriptions.
Some doctors are nonetheless ringing alarm bells that the country — and Europe — cannot be complacent.
“There are these differences that make us more protective than in the U.S.,” said Aina Perelló Bratescu, a family doctor in Catalonia who studies opioid prescriptions in the region. “But its not good to feel like theres no danger and everything is OK.”
Of particular concern is Spains spike in prescriptions for rapid release fentanyl, which doubled from 2010 to 2016. These drugs — often administered by a nasal spray or chewing tablets — are 50 to 100 times stronger than morphine. This worrying trend prompted the Spanish health ministry to update its prescription guidelines and convene a working group to discuss the issue.
Oxycodone prescriptions have increased in the Netherlands; Europe has tighter regulations on opioid prescriptions than the U.S. | Eva Hambach/AFP via Getty Images
This is another country
Experts in Spain are quick to point out how different the environment is from the U.S.
Víctor Mayoral, the secretary of the Spanish Society of Pain (SED) and a pain doctor in Catalonia, said practices like doctor-shopping — going from doctor to doctor to get more prescriptions — simply arent possible in Spain thanks to the national rollout of electronic prescriptions five years ago.
Another big difference, according to Mayoral, is that the country is constantly on alert for prescription abuse. For example, on the local level in Catalonia, when someone is prescribed a “high dose” of an opioid (more than 90 milligrams of morphine, for example) he and the regional department of health pharmacists investigate the prescription, sometimes literally meeting at his house to discuss whether the prescription for a patient is accurate.
Spain has also taken steps to avoid conflict-of-interest problems that have drawn attention in the U.S. For example, Spain forbids pharma reps from taking doctors out for meals more than €60.
In addition, Spain adheres to an EU law that says pharma companies cannot provide doctors with drug samples.
Meanwhile, advertising standards vary greatly between the two continents. Pharma companies can advertise for aspirin and paracetamol in Spain. But opioids?
“The problem is that each time you feel the effect less. You need more doses, and more frequently” — Flora, an arthritis sufferer
“No, no, no,” Mayoral said.
And the doctors insist these measures are shoring up the country against a U.S.-style opioid epidemic.
“We are prepared if the tsunami comes to Europe in the next years,” said SED President Juan Antonio Micó, talking on the sidelines of a recent event in Valencia. “But at this present moment, I dont think its possible in Europe.”
A ticking time bomb
Some patients disagree.
“I think it is only a matter of time … that the problem of opioids in Spain is unleashed so much that it is impossible to silence it much more,” said one patient, Flora, age 44.
Flora has degenerative arthritis. After other pain relievers became ineffective, her doctors had her try opioids. She started with moderate ones like tramadol, but once that stopped working, her general practitioner, in coordination with her neurosurgeon, moved her on to more intense opioids.
Quickly, those became less and less effective. “The problem is that each time you feel the effect less,” she said. “You need more doses, and more frequently.”
A skeleton sculpture made from oxycontin and methadone prescription bottles sits in front of the White House in Washington, D.C., on August 30, 2019. The U.S. opioid epidemic claimed about 70,000 lives in 2017 alone | Brendan Smialowski/AFP via Getty Images
At some point, she was faced with a hard choice: She could either decrease her pain, or move her finger.
Flora was becoming increasingly tolerant to the fentanyl patches she was taking, and if she wanted to stop feeling pain, she would need more. More fentanyl, though, would leave her physically unable to move.
This is when she knew she was dependent.
“I couldnt go without them, but when I took them I couldnt do anything at all,” said Flora, who used a different name for this article.
Perelló, the doctor, said its sometimes difficult to tell whether opioids such as fentanyl patches are “over-prescribed.” When theres a patient in serious pain, how does a doctor choose the right balance between relieving a patients pain and creating an addict?
Rapid release fentanyl, though, is easier to judge because its supposed to be used only for cancer patients, she said. In a 2018 regional study of 43,000 patients given strong opioids in Catalonia, the Catalan Health Service found 43 percent of the rapid release fentanyl prescriptions were for non-oncological pain. Another 20 percent were given high doses of opioids.
When asked about these numbers, a spokesperson for Spains pharma association Farmaindustria responded that companies can only promote medicines like rapid release fentanyl for their indicated use — in other words, theyre staying within their legal guidelines.
“When the pain comes so strong it relaxes me and takes away the pain, but at what price?” — Hasan, patient on pain medication
But these numbers, Perelló said, are still worrying.
“We are giving it to them like there is no danger,” she said.
Mostly commonly, Perelló said, she sees older women with chronic pain given fentanyl patches. It might help address their pain, but they are also left unable to move in their apartments.
Perelló said she also sees younger people who are prescribed the drugs over a long period of time — and the doctors are “making addicts.”
56-year-old Hasan is one of them. He was injured in an accident as a construction worker at the age of 32, and began with a host of pain relievers to tackle the pain. Then, 12 years ago, he went to a pain clinic and was prescribed a high dose of fentanyl.
That kind of dosage is “for terminal cancer patients who will die, which is not my case,” Hasan said. The drugs made him feel “doped all day.”
Hasans general practitioner realiRead More – Source
Spain’s coronavirus incidence rate falls for the first time this year, but pressure on ICUs rises
The third wave of the coronavirus has pushed Spain to the breaking point. According to the Spanish Health Ministry’s latest report, released on Thursday, the country has started to flatten the curve of new infections, but it has done so at crisis levels, with pressure on hospitals, especially in intensive care units (ICUs), close to unbearable. This pressure continues to rise across almost all of Spain.
The last 10 months of the pandemic have shown that there is not one but various peaks in a wave. The first is the number of new infections. The second is the spike in hospital admissions, which tends to happen a week later, and takes a little longer to be reflected in ICU figures. The final peak, which indicates a change in trend, is the number of deaths. The Health Ministry added 515 fatalities to the official count on Thursday, a terrible toll that is likely to remain at these levels for days to come while Spain transitions from peak to peak.
The latest data indicates that Spain is starting to see the other side of the peak of new infections in the third wave. A week ago, the Health Ministry reported a record-high 44,357 new coronavirus figures. On Thursday, that figure fell to 34,899. It is also the first day this year that the national incidence rate has fallen: the 14-day cumulative number of cases per 100,000 inhabitants now stands at 890, down from 900 on Wednesday.
Hospital admissions fell for the first time this year on Wednesday, with the percentage of Covid-19 patients in hospital wards dropping to 24.10%, down slightly from 24.03% on Tuesday. This data point fell again on Thursday, although the drop was again only marginal. But pressure continues to mount in Spain’s ICUs, which are the last line of defense of the healthcare system. If they are overwhelmed, authorities may be forced to introduce tougher restrictions, such as home confinement. Making matters worse, the pressure on ICUs is rising amid the uncertainty over how the emergence of new, more contagious strains of the coronavirus, such as the B.1.1.7 variant detected in the United Kingdom, will impact the pandemic in Spain.
“According to the data we have, we can expect that it [the B.1.1.7 variant] will be the dominant one in Spain by the end of February or the first fortnight of March. This has some implications because the strain is more transmittable,” said Fernando Simón, the director of the Health Ministry’s Coordination Center for Health Alerts (CCAES), at a government press conference on Thursday. The health official previously said this would not happen until a later date.
Simón admitted that there are small areas in Spain where the new strain already accounts for 20% of cases, but said nationally this figure was “around 8%.” With respect to restrictions, the health official said that “the measures that must be taken” are the same for the new and old variants of the coronavirus. “More measures can still be implemented without modifying the state of alarm,” he said, in reference to the emergency decree that gives regional governments – which are responsible for managing the health crisis – the power to introduce measures such as perimetral lockdowns, but not home confinement.
The figures released on Thursday also do not reflect how the coronavirus situation differs between each of Spain’s 17 regions. Indeed, the fall in hospitalizations over the past two weeks is mainly due to improvements in two regions: Valencia (which, despite this, remains in a “very critical situation,” said Simón) and Catalonia, which reported 466 fewer occupied beds on Thursday than on Tuesday. In Castilla y León, Galicia and Andalusia, there continue to be more hospital admissions than discharges.
“There are 11 regions where the situation is stabilizing or on a downward trend, but this is not the same as a fall in the hospital occupancy rate. The pressure on hospitals will continue over the coming days,” said Simón.
Andalusia and Galicia, as well as Murcia and Valencia, are some of the regions that are being hardest hit by the third wave of the pandemic, with the situation even worse than what it was during the first wave.
The big problem continues to be in ICUs. On Thursday, the Health Ministry reported 97 more ICU admissions than on Wednesday, and no region has managed to clearly reverse the upward trend. In other words, the peak of ICU pressure is still to come. In more than half of Spain, Covid-19 patients occupy more than 40% of all ICU beds – a similar figure to all other diseases combined. In the Balearic Islands, Castilla y León and Extremadura, the occupancy rate is more than 40%; in Castilla-La Mancha, Catalonia, Madrid and La Rioja, it is more than 50%; and in Valencia, it is 63%, a record high not seen since April last year, during the first wave.
As experts warned, the source of the problem is that Spain entered the third wave – which started after the December 6 long weekend – before the second wave was over. This meant that the ICU occupancy rate of Covid-19 patients, which was below 15% in October when the number of new cases began to rise, was already at around 30% in some regions when the third wave hit.
Covid-19 vaccine doses going to waste in some of Spain’s regions due to unsuitable syringes
Spanish regions such as Andalusia, Catalonia and Madrid are wasting thousands of doses of the Pfizer-BioNTech Covid-19 vaccine by not injecting patients with the sixth dose contained in the vials. Since January 8, when the European Medicines Agency granted authorization, the five initial doses contained in the vials are now officially six, increasing the number of potential recipients.
But this change has not been exploited by a number of Spain’s territories, who are in charge of their own vaccination campaigns. Speaking on Thursday in the regional parliament, Andalusia’s health chief Jesús Aguirre admitted that this was the case. “You could take out up to five doses and there was a wee drop left, and that little bit is used to administer that sixth dose,” he said. “But we are talking about 20% more vaccinations.”
The Andalusian regional government has blamed the failure to use this dose on a “deficit of 0.1-millimeter syringes,” the type that is usually used to inject insulin or in pediatrics, and has promised to solve the issue. The extraction of the sixth dose is more difficult with the 0.2-millimeter syringes also being used to administer the vaccines.
Based on the information offered by Spain’s regions, it is impossible to calculate how much of the vaccine has been wasted. Catalonia, for its part, has admitted it is only using the sixth dose from “two-thirds” of the vials. The region has administered more than 165,000 doses of the Pfizer-BioNTech vaccine so far, which would suggest wastage of around 10,000 doses.
A similar situation is playing out in Madrid, which on Thursday announced the purchase of 280,000 syringes in order to take advantage of this sixth dose. This is a low amount, however, compared to the millions of suitable syringes that have been purchased by regions with a much smaller population, such as Murcia and the Balearic and Canary Islands. The Madrid region has stated that in “the majority of cases” it is managing to use the sixth dose, but it has offered little extra information.
Aragón, which purchased 1,870,000 syringes in September, says that it has managed to use “100% of the first five doses from each vial and 81% of the sixth, which is 97% of the total.” Castilla-La Mancha, meanwhile, puts the percentage at 90%, while Asturias, Castilla y León and the Basque Country opted not to provide figures when consulted by EL PAÍS. The rest of the regions, however, stated that the use of the sixth dose is widespread across their territories.
Meanwhile, Spain’s regions are having to improvise a response to news that politicians, retired health workers and relatives of medical staff are jumping the line and receiving the Covid-19 vaccine ahead of their time. Currently, Spain is still in the first stage of the vaccination campaign, which is focussing on senior home residents, their carers, front-line medical workers and adults with serious disabilities.
The Health Ministry and the country’s regions have been working on the vaccination plan since September, but the scheme has failed to adequately set out how the order of the vaccinations should be supervised, and whether there should be some kind of sanction or punishment for those who jump the line or indeed what to do with unused doses.
The excuses offered so far by those who have got the vaccine early range from “wanting to boost confidence” in the vaccination, to claims of making use of “leftover doses.”
EL PAÍS has requested information from the country’s health departments as to the measures being taken against these irregularities. The majority have not responded. Extremadura, Madrid and Navarre claim that they are observing protocols, while Valencia, La Rioja, Andalusia and the Basque Country explain that they are cross-referencing databases: anyone who is found to have been given the vaccine despite not being on the list of phase one recipients must offer an explanation.
Health Minister Salvador Illa said this week that “proper planning” must be put in place to avoid wasting injections, adding that any sanctions for breaking protocol are the responsibility of the regions. For now, none of Spain’s regional governments have confirmed whether or not they have levied sanctions against offenders.
No second dose
One decision that has been made, however, is that Valencia is opting not to administer the second vaccine dose to anyone who has jumped the line. This includes, for example, the Socialist Party (PSOE) mayors of the municipalities of El Verger, Els Poblets and Rafelbuñol, who were found to have skipped the protocol and were given the vaccines in senior homes.
The PSOE premier of the region, Ximo Puig, has taken the decision not to administer the second dose to the 150 to 185 people thought to have jumped the line. They will instead be fully vaccinated when it is their turn, he insisted.
But Fernando Simón, the director of the Health Ministry’s Coordination Center for Health Alerts (CCAES) and the government’s most visible face during the coronavirus crisis, criticized the approach. “I understand that people who were vaccinated when they shouldn’t have been should admit their responsibility,” he said when asked by reporters about the incidents. “But from my point of view, I believe it would committing two errors: vaccinating people ahead of time and not administering the second vaccine.”
The issue is whether it is worse to waste the first dose by not giving the second one 21 to 42 days later, as stipulated by the manufacturer, or to fully immunize those who jumped the line. The Pfizer-BioNTech vaccine needs two doses for the recipient to develop 94% immunity to Covid-19, according to clinical trials. The regional government has said that it respects Simón’s opinion but that this was “a matter of institutional credibility.” The aforementioned mayors who jumped the line have been suspended from the party and their local councils will be deciding whether or not they should be fired.
Coronavirus cases in Spain officially top two million
The number of coronavirus cases recorded in Spain since the beginning of the pandemic officially exceeded two million on Thursday, amid warnings of difficult weeks ahead. According to the Health Ministry’s latest report, all data points clearly indicate that the pandemic continues to follow an upward trend. Thursday’s report – which also included figures from Wednesday as it was a public holiday (the Health Ministry does not release data on holidays or over the weekend) – registered 42,360 new coronavirus cases. The 14-day cumulative number of cases per 100,000 inhabitants now stands at 321, up from 296 on Tuesday. The number of Covid-19 patients in hospital and intensive care units (ICUs) rose by 1,514 and 134, respectively. Thursday’s report added 245 Covid-19-related deaths to the official toll.
But the Health Ministry does not believe the rising trend will impact the return to school, which has already happened in some regions, and will begin on Monday in others. When asked about the possibility of closing schools on Thursday, health official María José Sierra replied: “We do not recommend it.”
“It [schools] is one of the areas that have worked best, where there has been the most control. There were no outbreaks,” said Sierra, from the Health Ministry’s Coordination Center for Health Alerts (CCAES), who was standing in for the center’s director, Fernando Simón. The health official highlighted the enormous social and learning impact of closing schools and said that any new measures would target sectors that are hubs for contagions.
On the question of a new home lockdown, which has been introduced in countries like the United Kingdom, Sierra replied: “There are many measures to take before a strict confinement.” The health official defended the use of partial restrictions, like perimetral lockdowns and limits on social gatherings, which “proved their effectiveness” during the second wave of the pandemic. On November 9, Spain recorded its highest incidence rate when the 14-day cumulative number of cases per 100,000 inhabitants reached 529. The incidence rate began to fall after that date until rising again at the beginning of December.
It is important to note that Thursday’s report recorded a 25-point rise in Spain’s incidence rate even though the 14-day cumulative number includes three public holidays (Christmas, New Year’s Day, King’s Day), when there is typically underreporting. What’s more, fewer PCR and antigen tests have been carried out: while 140,000 tests were being done every day in the middle of December, between December 28 and January 3 – the last week with complete data – only 110,000 tests were administered in the entire week.
With fewer tests being done – most of which are carried out on patients with symptoms –, the positivity rate i.e. the percentage of tests that come back positive out of the total, has also risen. While 20 days ago this figure stood at 8%, it rose to 13.5% last week and to 15.6% on January 4. But experts warn the rise suggests that many chains of transmission are going undetected.
“It is a trend that is worrying us,” said Sierra on Thursday, who added that the weekly positivity rate exceeded 15% in five regions and 20% in three. “Among suspected cases diagnosed in primary healthcare centers, [the positivity rate] is already close to 30%,” she added.
According to Thursday’s report, Extremadura has the highest incidence rate in Spain, recording a 14-day cumulative number of cases per 100,000 inhabitants of 717. It is followed by the Balearic Islands (529) and Madrid (452). Asturias, Andalusia and the Canary Islands are the only regions where the incidence rate is below 200.
Hospital and ICU admissions – considered one of the most objective indicators of the pandemic – also rose significantly since Tuesday. A total of 14,543 Covid-19 patients are currently admitted to hospital, occupying 11.9% of all hospital beds. The occupancy rate in ICUs is 24%, with 2,307 patients in intensive care.
Sierra confirmed that Spain has detected nearly 50 cases of the new, more contagious strain of the coronavirus that was discovered in the United Kingdom, while many more cases are being studied.
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